Surgical implant and method and instrument for installing the same

ABSTRACT

A surgical implant comprising a receiver member and deployment member for clamping and sealing tissue of variable thickness, a corresponding applicator tool and surgical system for connecting, sealing, fastening and/or attaching tissue to itself, to other tissue and/or to non-tissue structures, and/or sealing the flow of fluid at and/or between structures such as tissue and vessel structures.

CROSS-REFERENCES TO RELATED APPLICATIONS

This is application is a continuation-in-part of International PatentApplication No. PCT/US15/18839, filed on Mar. 4, 2015, pursuant to 35USC § 365(c), which in turn claims benefit of priority to U.S.Provisional Application No. 61/947,956, filed on Mar. 4, 2014. Thisapplication is also a continuation-in-part of U.S. patent applicationSer. No. 14/641,136, filed Mar. 4, 2015 (pending), pursuant to 35 USC §120, which is a continuation of International Patent Application No.PCT/US15/18839, filed on Mar. 4, 2015, pursuant to 35 USC § 363, whichin turn claims benefit of priority to U.S. Provisional Application No.61/947,956, filed on Mar. 4, 2014. This application is also acontinuation-in-part application of U.S. patent application Ser. No.14/639,113, filed Mar. 4, 2015 (pending), pursuant to 35 USC § 120,which is a continuation of International Patent Application No.PCT/US15/18839, filed on Mar. 4, 2015, pursuant to 35 USC § 363, whichin turn claims benefit of priority to U.S. Provisional Application No.61/947,956, filed on Mar. 4, 2014. This application also claims thebenefit of priority to U.S. Provisional Application No. 62/214,190,filed on Sep. 3, 2015 pursuant to 35 USC § 119. The entire disclosuresof the afore-listed applications are expressly incorporated by referenceherein.

TECHNICAL FIELD AND INDUSTRIAL APPLICABILITY

The present disclosure relates to devices, systems, tools, and/ormethods useful for connecting, sealing, fastening, and/or attaching toitself or other tissue and/or non-tissue structures, and/or sealing theflow of fluid at and/or between structures such as tissue and vesselstructures of a human or non-human mammal.

BACKGROUND

In the discussion of the background that follows, reference is made tocertain structures and/or methods. However, the following referencesshould not be construed as an admission that these structures and/ormethods constitute prior art. Applicant expressly reserves the right todemonstrate that such structures and/or methods do not qualify as priorart.

Various devices and tools are known in the medical arts for sealing theflow of fluid through tissue structures in a patient. Common examplesinclude bipolar, monopolar, and other radiofrequency (RF) and thermalenergy sealers, staplers, and two-part fasteners. While these devicesgenerally work for their intended uses, each solution is not without itstradeoffs. For example, RF and thermal energy sealers require theavailability of a source of energy as well as high power requirementsand can scorch or burn tissue due to overheating. Medical staplers andtwo-part fastener appliers must be accurately and precisely tolerancedduring manufacture and aligned during use in order to ensure properengagement and functioning with respect to the tissue chosen forstapling. Medical staplers and two-part fastener appliers are alsogenerally configured for certain tissue sizes and thicknesses and do notaccommodate easily various tissue thicknesses. In view of these andother tradeoffs, there is the ever-present desire for new and alternatedevices and tools for connecting tissue to itself or other tissue andnon-tissue structures, and/or sealing the flow of fluid at and/orbetween tissue structures of a patient.

SUMMARY

A surgical implant according to an example embodiment of the presentdisclosure comprises a deployment member having a first base with afirst tissue contacting surface. At least one fastener is disposedwithin the deployment member. A receiver member has a second base with asecond tissue contacting surface facing the first tissue contactingsurface of the deployment member. A retainer is embedded within thesecond base of the receiver member. The fastener is movable with respectto and penetrable through the deployment member, receiver member and anytissue located therebetween to engage the retainer, and whereinengagement of fastener and the retainer couples the deployment andreceiver members together.

A surgical implant according to another example embodiment of thepresent disclosure comprises a base having a tissue contacting surfaceand a first thickness. A suspension having a second thickness extendsfrom the base opposite to the tissue contacting surface. A fastener,movable with respect to the base, is coupled to the suspension tocompress the suspension as the fastener is inserted into the base.

According to the example embodiment, the suspension can be a resilient,compressible member configured as a tower.

A surgical apparatus according to another example embodiment of thepresent disclosure comprises a body and a shaft extending distally fromthe body. An end effector disposed at a distal end of the shaft includesa first jaw and a second jaw. The first jaw is receivable of a firstportion of a surgical implant, and the second jaw is receivable of asecond portion of a surgical implant. The first and second jaws arerelatively movable with respect to one another between an open positionwherein the first and second jaws are spaced apart and a closed positionwherein the first and second jaws are proximate to one another. A driverfor transitioning the first and second jaws to the closed positionengages the first and second jaws, wherein moving the driver distallywith respect to the first and second jaws compresses the first andsecond jaws with respect to one another. An actuator coupled to thedriver transfers an actuation force to the driver to transition thefirst and second jaws to the closed position via tension.

A surgical implant applicator according to another example embodiment ofthe present disclosure comprises a main body and a shaft extendingdistally from the main body. First and second jaws disposed at a distalend of the shaft are relatively movable with respect to one another. Adriver is movably mounted to the first and second jaws for closing thejaws and deploying tissue fasteners of a surgical implant positionablewithin the first and second jaws. A trigger is operatively associatedwith the driver, wherein actuation of the trigger closes the jaws aswell as advances the driver towards a distal end of the first and secondjaws. Subsequent actuation of the trigger after the driver has reachedthe distal end of the first and second jaws induces movement of thedriver towards a proximal end of the first and second jaws.

According to an example embodiment, the driver can further include ablade positioned to engage and sever tissue as the driver is moved alongthe first and second jaws.

According to an example embodiment, the applicator can further include asafety mechanism comprising a user actuation rod. When oriented in afirst safety position, the rod inhibits movement of the driver until thefirst and second jaws are closed.

According to an example embodiment, the rod is spring biased to assumethe first position.

According to an example embodiment, the rod is locked in a secondposition to allow the driver to advance from the proximal end to thedistal end of the first and second jaws.

According to an example embodiment, the applicator further includes adrive mechanism operatively associated with the trigger, driver andsafety mechanism. The drive mechanism comprises a flange having ashoulder that abuts the rod when the rod is oriented in the firstposition. The drive mechanism further includes two ratchet gears coupledto the trigger and positioned on opposite sides of the flange thatinduces rotation of the flange upon actuation of the trigger. Cablesoperatively associated with the ratchet gears and operatively associatedwith the driver and/or one of the first and second jaws transmit forcebetween therebetween.

According to an example embodiment, the rod has a variable diameteralong its length to selectively impede the rotation of the flange.

According to an example embodiment, the applicator can further comprisea quarter gear positioned between the two ratchet gears.

A method for using a surgical implant applicator according to anotherexample embodiment of the present disclosure comprises the steps ofactuating a trigger to (i) advance a driver towards a distal end offirst and second jaws of the applicator and (ii) deploy tissue fastenersof a surgical implant positioned within the first and second jaws,wherein the driver is movably mounted to the first and second jaws. Themethod further includes subsequently actuating the trigger after thedriver has reached the distal end of the first and second jaws to movethe driver towards a proximal end of the first and second jaws.

According to an example embodiment, the method can further includeorienting a rod of a safety mechanism in a first safety position toprevent movement of the driver until the first and second jaws axeclosed.

According to an example embodiment, the method can further comprisepositioning the rod in a second position to allow the driver to advancefrom the proximal end to the distal end of the first and second jaws.

According to an example embodiment, the method can further includeactuating a blade along a slot of the first and second jaws and severingtissue as the driver is advanced towards a distal end of the first andsecond jaws.

According to an example embodiment, the blade is actuated after thetissue fasteners on opposite sides of the blade have been deployed andsecure the tissue.

According to an example embodiment, the method can further comprisesevering a portion of the surgical implant upon actuation of the blade.

According to an example embodiment, the method can further comprisecompressing the surgical implant between the first and second jaws uponclosure of the jaws and subsequently further compressing the surgicalimplant between the closed first and second jaws upon advancing thedriver towards the distal end the jaws.

According to another embodiment, a surgical implant is providedincluding a fastener supporting member having a first surface. At leastone fastener is supported by the fastener supporting member. A receivermember has a second surface facing the first surface of the fastenersupporting member. A retainer is positioned within the receiver member.At least one fastener is deployable from the fastener supporting membertoward the receiver member to engage the retainer within the receivermember. Engagement of the retainer by the at least one fastener couplesthe fastener supporting member and the receiver member together.

According to another embodiment, a surgical implant is providedincluding a fastener carrying member supporting a plurality of fastenershaving penetrating tips, the fastener carrying member having a firsttissue contacting surface. A receiver member has a second tissuecontacting surface. The first and second tissue contacting surfaces arepositionable opposite each other so that tissue to receive the pluralityof fasteners is positionable between the first and second tissuecontacting surfaces. Deployment of the fasteners moves the penetratingtips of the fasteners through the fastener carrying member and throughthe tissue between the first and second tissue contacting surfaces andinto the receiver member to couple the receiver member and fastenercarrying member.

According to another embodiment, a surgical implant is providedincluding a fastener supporting member having a first surface. At leastone fastener is supported by the fastener supporting member. At leastone compressible member extends from the fastener supporting member. Areceiver member has a second surface facing the first surface of thefastener supporting member. Deployment of the at least one fastenertoward the receiver member compresses the at least one compressiblemember.

According to another embodiment, a surgical implant is providedcomprising a fastener carrying member supporting a plurality offasteners and a plurality of compressible members, each of the fastenersengageable with one of the compressible members. The plurality offasteners are deployable through the fastener carrying member, whereindeployment of the plurality of fasteners compresses the compressiblemembers.

According to another embodiment, a surgical implant is providedincluding a fastener supporting member and a plurality of fastenersarranged along a longitudinally extending row substantially parallel toa longitudinal axis of the implant. A retainer is positioned in thefastener supporting member and has a plurality of openings. Theplurality of fasteners are retained by engagement with the plurality ofopenings in the retainer. A plurality of compressible members areengageable by the plurality of fasteners, and the plurality ofcompressible members are compressed by the plurality of fasteners.

According to another embodiment, a surgical implant is providedconfigured to accommodate a range of tissue thicknesses, the implantincluding first and second fasteners and first and second compressiblemembers. The first fastener is engageable with the first compressiblemember and the second fastener is engageable with the secondcompressible member. The first compressible member is compressible inaccordance with a distance of advancement of the first fastener and thesecond compressible member is compressible in accordance with a distanceof advancement of the second fastener. The distances of advancement ofthe first and second fasteners are dependent on a tissue thicknessthrough which the fasteners advance.

According to another embodiment, a surgical implant is providedincluding a fastener supporting member having a first surface. Aplurality of fasteners are supported by the fastener supporting member.The plurality of fasteners have a penetrating tip and are deployable ina first direction. A receiver member is configured to receive theplurality of fasteners. A plurality of counterforce members extend fromthe fastener supporting member to apply a counterforce on the pluralityof fasteners when the plurality of fasteners have been deployed. Thecounterforce members apply a force against the plurality of fasteners ina second direction opposite a first direction of deployment of theplurality of fasteners.

According to another embodiment, a surgical implant is providedincluding a receiver member, a fastener supporting member and aplurality of fasteners supported on the fastener supporting member andarranged along a longitudinally extending row substantially parallel toa longitudinal axis of the fastener supporting member. The fasteners areengageable with the receiver member. The fastener supporting member andthe receiver member have a width and length exceeding the width, and thefasteners couple the fastener supporting member and the receiver membertogether and pull the receiver member toward the fastener supportingmember after coupling the fastener supporting member and receivermember.

According to another embodiment, a surgical method of sealing tissue isprovided including providing a fastener supporting member supporting aplurality of fasteners and having a plurality of compressible members.The method further includes providing a receiver member and clampingtissue between a first surface on the fastener supporting member and asecond surface on the receiver member. The fasteners are advanced intothe receiver member and compress the compressible members in accordancewith a distance of advancement of the fasteners, the distance relatingto a thickness of tissue between the first and second surfaces.

According to another embodiment, a surgical method of fasteningparenchyma is provided including providing a fastener supporting membersupporting a plurality of fasteners and a receiver member to receive theplurality of fasteners when advanced from the fastener supportingmember. Parenchyma is clamped between a first surface on the fastenersupporting member and a second surface on the receiver member. Thefasteners are advanced in a first direction from the fastener supportingmember into the receiver member to couple the fastener supporting memberand the receiver member, wherein a counterforce is applied to each ofthe fasteners in a direction opposite to the first direction ofadvancement of the plurality of fasteners thereby accommodating forvariations in tissue thickness.

According to another embodiment, a surgical method of forming ananastomosis between a first structure and a second structure within abody of a patient is provided, the method including providing a fastenersupporting member supporting a plurality of fasteners, positioning thefastener supporting member adjacent the first structure, providing areceiver member and positioning the receiver member adjacent the secondstructure. The fasteners are advanced through the fastener supportingmember and into the receiver member to couple together the fastenersupporting member and the receiver member.

According to another embodiment, an end effector assembly of a surgicaldevice is provided, the end effector assembly including a first jaw anda second jaw. At least one of the first and second jaws is movabletoward the other jaw to transition the first and second jaws between anopen configuration and a closed configuration. The first jaw and thesecond jaw are arranged to receive tissue therebetween when in the openconfiguration and to clamp the tissue when in the closed configuration.A fastener supporting member is supported by the first jaw. A pluralityof fasteners is supported by the fastener supporting member and areceiver member supported by the second jaw. A retainer is positioned inthe second jaw. A drive assembly is movable with respect to the firstjaw to advance the plurality of fasteners toward the receiver member andinto engagement with the retainer to couple together the fastenersupporting member and the receiver member.

According to another embodiment, an end effector assembly of a surgicaldevice is provided. The end effector assembly includes a first jaw and asecond jaw. At least one of the first and second jaws is movable towardthe other jaw to transition the first and second jaws between an openconfiguration and a closed configuration. The first jaw and the secondjaw are arranged to receive tissue therebetween when in the openconfiguration and to clamp tissue when in the closed configuration. Afastener supporting member is supported by the first jaw. A plurality offasteners is supported by the fastener supporting member. A plurality ofcompressible members is supported by the first jaw and engageable by thefasteners. A receiver member is supported by the second jaw. A driveassembly is movable with respect to the first jaw to advance theplurality of fasteners toward the receiver member. The plurality offasteners compress the plurality of compressible members in accordancewith a thickness of tissue clamped between the first and second jaws.

According to another embodiment, an end effector assembly of a surgicaldevice is provided. The end effector assembly includes a first jaw and asecond jaw. At least one of the first and second jaws is movable towardthe other jaw to transition the first and second jaws between an openconfiguration and a closed configuration. The first jaw and the secondjaw are arranged to receive tissue therebetween when in the openconfiguration and to clamp tissue when in the closed configuration. Afastener supporting member is supported by the first jaw, a plurality offasteners is supported by the fastener supporting member, and a receivermember is supported by the second jaw. A drive assembly is movable withrespect to the first jaw to advance the plurality of fasteners in afirst direction toward the receiver member against a counterforceapplied to the plurality of fasteners. The fasteners are engageable withthe receiver member and the counterforce applies a force to thefasteners in a second direction opposite the first direction when thefasteners are engaged with the receiver member.

According to another embodiment, a surgical device is provided includinga handle portion at a proximal portion of the device. An elongatedportion extends distally from the handle portion. A first jaw and asecond jaw are at the distal portion of the device. A fastenersupporting member of a surgical implant is supported in the first jaw,the fastener supporting member supporting a plurality of surgicalfasteners. A fastener receiver member of the surgical implant issupported in the second jaw. A drive assembly is actuable from thehandle portion to advance the plurality of fasteners. The fasteners areadvanced in a first direction toward the receiver member and engageabletherewith to couple the fastener supporting member and receiver memberand to exert a force to pull the receiver member toward the fastenersupporting member after engagement of the plurality of fasteners withthe receiver member.

According to another embodiment, a surgical device is provided includinga handle portion at a proximal portion of the device. An elongatedportion extends distally from the handle portion. A first jaw and asecond jaw are at a distal portion of the device. A fastener supportingmember of a surgical implant is supported in the first jaw, the fastenersupporting member supporting a plurality of surgical fasteners. Afastener receiver member of the surgical implant is supported in thesecond jaw. A plurality of compressible members interact with theplurality of fasteners. The compressible members have a firstconfiguration prior to advancement of the plurality of fasteners and asecond configuration subsequent to advancement of the plurality offasteners. A drive assembly is actuable from the handle portion tosequentially advance the plurality of fasteners against the plurality ofcompressible members. The plurality of fasteners moves at least some ofthe plurality of compressible members to the second configuration.

According to another embodiment, a surgical device is provided includinga handle portion at a proximal portion of the device. An elongatedportion extends distally from the handle portion. A first jaw and asecond jaw are at the distal portion of the device. A fastenersupporting member of a surgical implant is supported in the first jaw. Aplurality of fasteners is supported by the fastener supporting member,and a fastener receiver member of the surgical implant is supported inthe second jaw. A retainer is included, and a drive assembly actuablefrom the handle portion advances the plurality of fasteners toward andinto engagement with the retainer. The fasteners are engageable with theretainer to couple the fastener supporting member and receiver member.

According to another embodiment, a surgical device is provided includinga handle portion at a proximal portion of the device and an actuator. Anelongated portion extends distally from the handle portion. A first jawand a second jaw are at the distal portion of the device. At least oneof the first jaw and the second jaw is movable to transition the firstand second jaws between an open position and a closed position. Thefirst jaw and the second jaw are arranged to receive tissue therebetweenwhen in the open position and to clamp tissue when in the closedposition. A plurality of fasteners is supported by the first jaw. Adrive assembly is operably connected to the actuator and actuable by theactuator to advance the plurality of fasteners from the first jaw towardthe second jaw. The drive assembly includes a drive member movable withrespect to the first jaw. The drive member is movable in a firstdirection to advance the plurality of fasteners and movable in a seconddirection opposite the first direction after movement in the firstdirection to further advance at least one of the plurality of fasteners.

According to another embodiment, a surgical device is provided includinga handle portion at a proximal portion of the device. The handle portionincludes a movable handle member and an elongated portion extendsdistally from the handle portion. A first jaw and a second jaw are atthe distal portion of the device. At least one of the first jaw and thesecond jaw is movable to transition the first and second jaws between anopen position and a closed position. The first jaw and the second jaware arranged to receive tissue therebetween when in the open positionand to clamp tissue when in the closed position. A plurality offasteners is supported by the first jaw. First and second rotatablespools are included for moving a drive member. A first gear is operablyconnected to the handle member and operably connected to at least one ofthe first and second rotatable spools. Movement of the handle memberrotates the first gear which rotates at least one of the first andsecond rotatable spools to move the drive member to advance theplurality of fasteners into tissue.

According to another embodiment, a surgical device is provided forapplying fasteners including a handle portion at a proximal portion ofthe device and including an actuator. An elongated portion extendsdistally from the handle portion. A first jaw and a second jaw are atthe distal portion of the device. At least one of the first jaw and thesecond jaw is movable to transition the first and second jaws between anopen position and a closed position. The first jaw and the second jaware arranged to receive tissue therebetween when in the open positionand to clamp tissue when in the closed position. A plurality offasteners is supported by the first jaw. A drive assembly is operablyconnected to the actuator and actuable by the actuator to advance theplurality of fasteners from the first jaw toward the second jaw. Thedrive assembly includes a first tensioning member, a second tensioningmember and a pulley. The first tensioning member interacts with thepulley to effect advancement of the plurality of fasteners toward thesecond jaw.

According to another embodiment, a surgical implant is providedcomprising a fastener supporting member having a first surface and atleast one fastener supported by the fastener supporting member. Areceiver member has a second surface facing the first surface of thefastener supporting member. A retainer is positioned within the receivermember. A flexible flap extends from one or both of the fastenersupporting member and the receiver member, wherein the at least onefastener is deployable from the fastener supporting member toward thereceiver member to engage the retainer within the receiver member,wherein engagement of the retainer by the at least one fastener couplesthe fastener supporting member and the receiver member together.

In some embodiments, the flap extends radially from both sides of thereceiver member and the fastener supporting member. In some embodiments,the flap is formed integrally with the fastener supporting member andreceiver member. In some embodiments, the receiver member is formed of afirst material and the retainer is formed of a more rigid material thanthe first material of the receiver member, and the retainer extends intothe flap.

In some embodiments, the at least one fastener is deployable through thefastener supporting member and the retainer restricts movement of theleast one fastener in a direction opposite to a direction of deploymentof the at least one fastener after the at least one fastener engages theretainer. The retainer can include a mesh having a plurality ofopenings, wherein the at least one fastener is receivable within one ofthe openings. In some embodiments, the at least one fastener is deployedin a first direction toward the receiver member and is biased in asecond direction opposite the first direction.

In accordance with another embodiment, a surgical implant is providedcomprising a fastener carrying member supporting a plurality offasteners having penetrating tips and having a first tissue contactingsurface and a first radially extending flexible flap extending fromopposing sides of the fastener carrying member. A receiver member has asecond tissue contacting surface and a second radially extendingflexible flap extending from opposing sides of the receiver member. Thefirst and second tissue contacting surfaces are positionable oppositeeach other so that tissue to receive the plurality of fasteners ispositionable between the first and second tissue contacting surfaces,wherein deployment of the plurality of fasteners moves the penetratingtips of the fasteners through the fastener carrying member and throughthe tissue between the first and second tissue contacting surfaces andinto the receiver member to couple the receiver member and fastenercarrying member.

In some embodiments, a first retainer is positioned within the receivermember and/or a second retainer is positioned in the fastener carryingmember, and the penetrating tips of the fasteners extend through theretainers. The fastener carrying member can further include a pluralityof compressible members compressed by the plurality of fasteners whenthe fasteners are deployed.

In some embodiments, the first and second retainers extend into theflaps. The first flap in some embodiments can be formed of the samematerial as the fastener carrying member and/or the second flap can beformed of the same material as the receiver member.

In accordance with another embodiment, an end effector assembly of asurgical device is provided comprising a first jaw, a second jaw, atleast one of the first and second jaws movable toward the other jaw totransition the first and second jaws between an open configuration and aclosed configuration, The first jaw and the second jaw are arranged toreceive tissue therebetween when in the open configuration and to clampthe tissue when in the closed configuration. A fastener supportingmember is supported by the first jaw, a plurality of fasteners aresupported by the fastener supporting member, and a receiver member issupported by the second jaw. A retainer is positioned in the second jawand a drive assembly is movable with respect to the first jaw to advancethe plurality of fasteners toward the receiver member and intoengagement with the retainer to couple together the fastener supportingmember and the receiver member. The drive assembly includes a driverhaving a camming surface directly engageable with the fasteners duringdistal movement thereof to advance the plurality of fasteners toward thereceiver member.

In some embodiments, the plurality of fasteners have a base and a pairof legs extending from the base, and the base is aligned substantiallyparallel to a longitudinal axis of the fastener supporting member.

In some embodiments, the plurality of fasteners have a curved surfacedirectly engageable by the driver. A plurality of compressible memberscan be provided in some embodiments positioned in the first jaw, whereinadvancement of the plurality of fasteners compresses the plurality ofcompressible members.

In some embodiments, the plurality of fasteners are arranged in at leasttwo rows substantially parallel to a longitudinal axis of the fastenersupporting member, and a cutting blade is movable between the rows offasteners to sever tissue.

In some embodiments, a first cable and a second cable are provided,wherein the first cable effects movement of the driver in a distaldirection and the second cable effects movement of the driver in aproximal direction.

According to another embodiment, an end effector assembly of a surgicaldevice is provided comprising a first jaw, a second jaw. At least one ofthe first and second jaws is movable toward the other jaw to transitionthe first and second jaws between an open configuration and a closedconfiguration. The first jaw and the second jaw are arranged to receivetissue therebetween when in the open configuration and to clamp thetissue when in the closed configuration. A fastener supporting member issupported by the first jaw and a plurality of fasteners are supported bythe fastener supporting member. A receiver member is supported by thesecond jaw and a drive assembly is movable with respect to the first jawto advance the plurality of fasteners into the receiver member to coupletogether the fastener supporting member and the receiver member. Thedrive assembly includes a driver having a distal camming surface and aproximal camming surface, the distal camming surface directly engageablewith the plurality of fasteners during distal movement thereof toadvance the plurality of fasteners and the proximal camming surfacedirectly engageable with the plurality of fasteners during proximalmovement thereof to further advance the plurality of fasteners.

In some embodiments, the plurality of fasteners have a base and a pairof legs extending from the base, the base aligned substantially parallelto a longitudinal axis of the fastener supporting member.

In some embodiments, the distal camming surface has a first regionhaving a first curve and a second region having a second differentcurve. In some embodiments, the first curve reduces the firing force oninitial advancement of the fastener and the second curve reduces thefiring force on final advancement of the fastener.

In some embodiments, the fasteners have a curved surface directlyengageable by the driver. In some embodiments, a plurality ofcompressible members are positioned in the first jaw, whereinadvancement of the fasteners compresses the compressible members. Thecompressible members can in some embodiments be in the form of towers,the towers having a channel therein to decrease lateral expansion of thetowers when compressed by the fasteners The end effector assembly caninclude guide surfaces which are in contact with a side of the fasteneropposite a side of the fastener contacted by the distal camming surface.

The end effector assembly can further include a retainer positioned inthe receiver member and the plurality of fasteners are advanced intoengagement with the retainer. The retainer can, in some embodiments,restrict movement of the least one fastener in a direction opposite to adirection of deployment of the at least one fastener after the at leastone fastener engages the retainer.

In some embodiments, the end effector assembly of includes a pluralityof channels through which the distal and proximal camming surfacestravel.

A first cable and a second cable can be provided wherein the first cableeffects movement of the driver in a distal direction and the secondcable effects movement of the driver in a proximal direction.

In some embodiments, the fastener supporting member and receiver membereach have a flap extending radially from each side of the receivermember and the fastener supporting member. In some embodiments, thefasteners are deployable through the fastener supporting member.

According to another embodiment, an end effector assembly of a surgicaldevice is provided comprising a first jaw and a second jaw. At least oneof the first and second jaws is movable toward the other jaw totransition the first and second jaws between an open configuration and aclosed configuration, wherein the first jaw and the second jaw arearranged to receive tissue therebetween when in the open configurationand to clamp the tissue when in the closed configuration. A fastenersupporting member is supported by the first jaw and a plurality offasteners are supported by the fastener supporting member. A receivermember is supported by the second jaw. A drive assembly is movable withrespect to the first jaw to advance the plurality of fasteners into thereceiver member to couple together the fastener supporting member andthe receiver member, the drive assembly including a driver having acamming surface having a first region having a first curve and a secondregion having a second different curve, wherein the first curve reducesa firing force on initial advancement of the fastener and the secondcurve reduces the firing force on final advancement of the fastener.

According another embodiment, a surgical implant is provided comprisinga fastener supporting member having a first surface, a plurality offasteners supported by the fastener supporting member, a receiver memberhaving a second surface facing the first surface of the fastenersupporting member, and a plurality of compressible members extendingfrom the fastener supporting member. The compressible members have asolid region extending in a direction away from the receiver member anda channel formed within the solid region, wherein deployment of the atleast one fastener toward the receiver member compresses the at leastone compressible member.

In some embodiments, the surgical implant has a first tissue contactingsurface on a first side of the fastener supporting member and thecompressible members extend from a second opposite side of the fastenersupporting member. In some embodiments, the compressible members are inthe form of a tower having a base and fasteners have a base engageablewith the base of the compressible members, the base of fastenersapplying a force to the base of the compressible members to deform theat least one compressible member.

In some embodiments, the receiver member includes a plurality of shieldsarranged along a row substantially parallel to a longitudinal axis ofthe receiver, each of the plurality of shields being positioned oppositea fastener. The extent of compression of the compressible members insome embodiments is dependent on a thickness of tissue clamped betweenthe fastener supporting member and the receiver member, and thecompressible members apply a counterforce to the fasteners in adirection opposite a direction in which the fasteners are deployed.

According to another embodiment, an end effector assembly of a surgicaldevice is provided comprising a first jaw and a second jaw movabletoward the first jaw between an open configuration and a closedconfiguration, wherein the first jaw and the second jaw are arranged toreceive tissue therebetween when in the open configuration and to clampthe tissue when in the closed configuration. A fastener supportingmember is supported in the second jaw and a plurality of fasteners aresupported by the fastener supporting member. A receiver member issupported by the first jaw and a drive assembly is movable with respectto the second jaw to advance the plurality of fasteners into thereceiver member to couple together the fastener supporting member andthe receiver member,

In some embodiments, the drive assembly includes a driver having adistal camming surface and a proximal camming surface, the distalcamming surface advancing the plurality of fasteners during distalmovement and the proximal camming surface advancing the plurality offasteners during proximal movement to further advance the plurality offasteners. In some embodiments, the second jaw has first and secondprotrusions, the first protrusion engageable with a first opening in thefirst jaw and the second protrusion engageable with a second opening inthe first jaw, wherein the first and second protrusions can beconfigured to snap over and into the first and second openings.

In some embodiments the end effector assembly further comprises aplurality of compressible members positioned in the second jaw, whereinadvancement of the plurality of fasteners compresses the plurality ofcompressible members. In some embodiments, the drive assembly isadvanceable at an angle of up to about 90 degrees to advance theplurality of fasteners.

In some embodiments, the end effector assembly further comprises aretainer positioned in the receiver member and the plurality offasteners are advanced into engagement with the retainer, wherein theretainer can be configured to restrict movement of the fasteners in adirection opposite to a direction of deployment of the fasteners afterthe fasteners engage the retainer. In some embodiments, the plurality offasteners are deployable through the fastener supporting member.

In some embodiments, the drive system includes a first cable and asecond cable, the first cable effects movement of the driver in a distaldirection and the second cable effects movement of the driver in aproximal direction. In some embodiments, the drive system includes adriver, and a pull force that moves the driver proximally is on anopening side of a moving jaw pivot to create a jaw opening moment and apull force that moves the driver distally is below the moving jaw pivotto create a jaw closing moment during advancement of the fasteners.

According to another embodiment, an end effector assembly of a surgicaldevice is provided comprising a first jaw and a second jaw movabletoward the first jaw between an open configuration and a closedconfiguration, wherein the first jaw and the second jaw are arranged toreceive tissue therebetween when in the open configuration and to clampthe tissue when in the closed configuration. A plurality of fastenersare supported in the second jaw. A driver is movable with respect to thefirst and second jaws, the driver movable along a first plane in adistal direction to advance the plurality of fasteners toward the firstjaw and subsequently movable in a second plane in a proximal directionto return to a proximal position,

In some embodiments, the driver is operable to transition the first andsecond jaws between the open configuration and the closed configuration.In some embodiments, when the driver is moved to a distal position, thejaws can move to a slightly open position. In some embodiments, thedriver can include a tab and the first jaw can include a first cammingsurface, the tab engaging the first camming surface to maintain the jawsin the closed configuration as the driver is advanced in the distaldirection. In some embodiments, the first jaw has an opening at a distalportion to receive the tab so the driver can move from the first planeto the second plane.

In some embodiments, the driver advances the plurality of fastenerstoward a receiver member in the first jaw and into engagement with aretainer in the receiver member, and the second jaw supports a pluralityof compressible members, wherein advancement of the plurality offasteners compresses the plurality of compressible members.

According to another embodiment an end effector assembly of a surgicaldevice is provided comprising a first jaw and a second jaw movabletoward the first jaw between an open configuration and a closedconfiguration, wherein the first jaw and the second jaw are arranged toreceive tissue therebetween when in the open configuration and to clampthe tissue when in the closed configuration. A fastener supportingmember is supported in the second jaw and a plurality of fasteners aresupported in the fastener supporting member. A receiver member issupported by the first jaw. A driver is movable with respect to thefirst and second jaws to advance the plurality of fasteners into thereceiver member to couple the fastener supporting member and thereceiver member together, the driver engageable with the first andsecond jaws as it travels distally to hold the first and second jawstogether and engageable with a surface of the first jaw to push thefirst jaw open as it moves proximally.

In some embodiments, when the driver moves to the distal position, thedriver moves in a direction away from the second jaw to allow the firstjaw to spring slightly open. In some embodiments, the driver includes atab engageable with a camming surface of the first jaw to hold the jawstogether.

In accordance with another embodiment, a loading assembly for a surgicalapplicator is provided having a first jaw and a second jaw. The loadingassembly comprises a housing and an implant contained within thehousing. The implant has a first portion and a second portion, the firstportion having a fastener supporting member supporting a pluralityfasteners and a plurality of compressible members. The second portionhas a receiver member and a retainer positioned within the receivermember. The housing is positionable within the jaws of the applicator totransfer the first portion to the first jaw and the second portion tothe second jaw.

In some embodiments, the housing is separable from the implant to leavethe implant in the first and second jaws. In some embodiments,transitioning of the first and second jaws to the closed positiontransfers the implant to the first and second jaws.

In some embodiments, the plurality of fasteners are deployable from thefastener supporting member toward the receiver member to engage theretainer within the receiver member to couple the fastener supportingmember and the receiver member together. The plurality of fasteners caninclude a plurality of fasteners arranged along at least one rowsubstantially parallel to a longitudinal axis of the fastener supportingmember. The receiver member can include a plurality of shields arrangedalong at least one row substantially parallel to a longitudinal axis ofthe receiver member with each shield positioned opposite one of theplurality of fasteners. In some embodiments, the retainer is embedded inthe receiver member and includes a plurality of strands and a pluralityof openings between the strands to receive the plurality of fasteners.In some embodiments, the receiver member is at least partially composedof silicone rubber

In some embodiments, the loading assembly has a slot at a proximalportion to engage a tab of the first jaw and/or at least one protrusionto snap into a slot of the first jaw.

In accordance with another embodiment, a loading assembly for reloadingan end effector of a surgical applicator is provided, the end effectorhaving a first jaw movable toward the second jaw to transition the jawsfrom an open configuration to a closed configuration. The loadingassembly comprises an implant having a first portion and a secondportion, the first portion having a fastener supporting membersupporting a plurality fasteners and the second portion having areceiver member. The implant is mountable within the first and secondjaws of the applicator upon placement of the first portion in the firstjaw and subsequent movement of the first jaw toward the second jaw.

In some embodiments, subsequent movement of the first jaw toward thesecond jaw transfers the first portion of the implant to the first jawand the second portion of the implant to the second jaw.

In some embodiments, the fastener supporter member includes a pluralityof compressible members compressible by the plurality of fasteners. Aretainer can be positioned within the receiver member.

In some embodiments, the loading assembly includes a housing and theimplant is removably positioned within the housing and transferable fromthe housing into the first and second jaws. In some embodiments, theloading assembly has at least one protrusion which snaps into a slot ofthe first jaw.

In accordance with another embodiment, a method of loading a surgicalimplant into a surgical applicator is provided comprising the steps ofproviding a housing having an implant including a plurality of fastenersand removably supported by the housing; placing the housing into a firstjaw of the applicator; closing the first jaw of the applicator; andremoving the housing from the implant to leave the implant within thefirst jaw of the surgical applicator.

In some embodiments the implant includes a receiver member, and the stepof closing the first jaw transfers the receiver member to the secondjaw. In some embodiments, the method further includes the steps ofplacing a proximal portion of the housing in engagement with a tab ofthe first jaw and subsequently rotating the housing toward the firstjaw. In some embodiments, the receiver is frictionally retained in thesecond jaw upon closing of the first jaw.

In accordance with another embodiment, a surgical device is providedcomprising a handle portion at a proximal portion of the device, anelongated portion extending distally from the handle portion, and an endeffector connected to a distal portion of the elongated portion andhaving a first jaw and a second jaw. At least one of the jaws is movabletoward the other jaw to effect transition of the jaws from an open to aclosed configuration. The end effector is connected for articulationwith respect to the elongated portion about a first axis and about asecond axis, the first and second axes intersecting.

In some embodiments, the device includes a first pair of tension ribbonsto effect articulation about the first axis and/or a second pair oftension ribbons to effect articulation about the second axis. In someembodiments, pulling a first ribbon of the first pair of ribbons in aproximal direction allows the second ribbon of the first pair of ribbonsto extend articulating the end effector in a first direction and pullingthe second ribbon of the first pair of ribbons in a proximal directionallows the first ribbon of the first pair of ribbons to extendarticulating the end effector in a second direction opposite the firstdirection. In some embodiments, pulling a first ribbon of the secondpair of ribbons in a proximal direction allows the second ribbon of thesecond pair of ribbons to extend articulating the end effector in athird direction different than the first and second directions andpulling the second ribbon of the second pair of ribbons in a proximaldirection allows the first ribbon of the second pair of ribbons toextend articulating the end effector in a fourth direction opposite thethird direction. In some embodiments, the first axis is a yaw axis andthe second axis is a pitch axis and the yaw and pitch axes intersect ata central point. In some embodiments, the first and second axes aresubstantially orthogonal to each other. In some embodiments, a rotatablejoint is connected to the first and second jaws and the first pair ofribbons attach to the rotatable joint in line with the second axis.

In some embodiments, the device includes a driver movable within thejaws to advance fasteners supported in one of the jaws, a first cableand a second cable, wherein the first cable effects movement of thedriver in a distal direction and the second cable effects movement ofthe driver in the proximal direction, and the first and second cables.In some embodiments, the first and second cables are contained in a tubewhich extends through the intersection of the first and second axes.

In some embodiments, the handle portion includes a movable handle, andinitial movement of the movable handle moves the drive assembly totransition the first and second jaws to a closed configuration andfurther movement of the movable handle advances fasteners in the firstjaw toward a receiver member in the second jaw.

In some embodiments, a fastener supporting member of a surgical implantis supported in the first jaw and supports a plurality of fasteners, anda fastener receiver member of the surgical implant is supported in thesecond jaw. In some embodiments a plurality of compressible membersinteract with the plurality of fasteners, the plurality of compressiblemembers having a first configuration prior to advancement of theplurality of fasteners and a second deformed configuration subsequent toadvancement of the plurality of fasteners.

In accordance with another embodiment, a surgical device is providedcomprising a handle portion at a proximal portion of the device, anelongated portion extending distally from the handle portion, and an endeffector connected to a distal portion of the elongated portion andhaving a first jaw and a second jaw, at least one of the jaws movabletoward the other jaw to effect transition of the jaws from an open to aclosed configuration. A fastener supporting member of a surgical implantis supported in the first jaw and supports a plurality of fasteners. Afastener receiver member of the surgical implant is supported in thesecond jaw. The end effector is articulatable with respect to theelongated portion for movement in first and second opposite directionsand third and fourth opposite directions.

In some embodiments, a first pair of tension ribbons and/or a secondpair of tension ribbons are provided, wherein the first pair of tensionribbons are positioned on opposing sides of a longitudinal axis of theelongated portion and the second pair of tension ribbons are positionedon opposing sides of the longitudinal axis. In some embodiments, a)pulling a first ribbon of the first pair of ribbons in a proximaldirection allows the second ribbon of the first pair of ribbons toextend articulating the end effector in a first direction, b) pullingthe second ribbon of the first pair of ribbons in a proximal directionallows the first ribbon of the first pair of ribbons to extendarticulating the end effector in a second direction opposite the firstdirection, c) pulling a first ribbon of the second pair of ribbons in aproximal direction allows the second ribbon of the second pair ofribbons to extend articulating the end effector in a third directiondifferent than the first and second directions and/or d) pulling thesecond ribbon of the second pair of ribbons in a proximal directionallows the first ribbon of the second pair of ribbons to extendarticulating the end effector in a fourth direction opposite the thirddirection.

In some embodiments, a plurality of compressible members interactingwith the plurality of fasteners are provided, the plurality ofcompressible members having a first configuration prior to advancementof the plurality of fasteners and a second configuration subsequent toadvancement of the plurality of fasteners.

In accordance with another embodiment, an articulation mechanism for anend effector of a surgical device is provided. The articulationmechanism comprises a pivot, first and second pitch ribbons connected tofirst and second portions of the pivot and third and fourth yaw ribbonsconnected to third and fourth portions of the pivot. The first andsecond ribbons are selectively tensionable to effect articulation of theend effector about a pitch axis and the third and fourth ribbons areselectively tensionable to effect articulation of the end effector abouta pitch axis.

In some embodiments, the pitch and yaw axis intersect at a centralpoint. In some embodiments, the third and fourth ribbons attach to thepivot in line with the pitch axis.

In accordance with another embodiment, a surgical device is providedcomprising a handle portion at a proximal portion of the deviceincluding a movable handle, an elongated portion extending distally fromthe handle portion, and a first jaw and a second jaw at a distal portionof the device. At least one of the jaws is movable toward the other jawto transition the first and second jaws from an open configuration to aclosed configuration. A fastener supporting member of a surgical implantis supported in the first jaw and supports a plurality of surgicalfasteners. A fastener receiver member of the surgical implant issupported in the second jaw. A drive assembly is actuable by the movablehandle to transition the first and second jaws between the open andclosed configurations and to advance the plurality of fasteners in afirst direction into engagement with the fastener receiver member tocouple the fastener supporting member and receiver member. A release isoperatively associated with the movable handle, the release movable froma first position to a second position to enable the movable handle toactuate the drive assembly to advance the plurality of fasteners.

In some embodiments, the release is movable to a third position, thethird position being between the first and second positions, wherein inthe third position the movable handle can be returned to an initialposition to transition the first and second jaws from the closedconfiguration back to the open configuration. In some embodiments, themovable handle is movable from an initial position to a second positionto effect transition of the first and second jaws to the closedconfiguration, and the movable handle can have a hook engageable with ahook receiving member to retain the movable handle in the secondposition. In some embodiments, movement of the release to the thirdposition releases engagement of the hook with the hook receiving memberbut prevents movement of the movable handle to actuate the driveassembly. In some embodiments, upon movement of the release to thesecond position, the first and second jaws cannot be transitioned to theopen configuration until the plurality of fasteners are advanced intothe receiver member.

In some embodiments, the movable handle is pivotable toward a stationaryhandle and the hook is positioned between the movable handle and thestationary handle. In some embodiments, the release is actuable by abutton positioned on the movable handle. The button can be biased in acounterclockwise direction.

The device can further include a ratchet wheel, and the ratchet wheelcan include a ridge to disengage a handle catch from the ratchet wheel.In some embodiments, the handle catch is biased against the ratchetwheel.

In some embodiments, a plurality of counterforce members are supportedwithin the first jaw, the plurality of fasteners engageable with theplurality of counterforce members, and the plurality of counterforcemembers biasing the plurality of fasteners in a second directionopposite the first direction. In some embodiments, the fasteners exert aforce to pull the receiver member toward the fastener supporting memberafter engagement of the plurality fasteners with the receiver member.

In some embodiments, the drive assembly is movable in a distal directionto advance the plurality of fasteners and movable in a proximaldirection to further advance at least one of the plurality of fastenersin the first direction, The device can include a first cable and asecond cable, the first cable effecting movement of the drive assemblyin a distal direction and the second cable effecting movement of thedrive assembly in the proximal direction.

According to another embodiment, a surgical device is providedcomprising a handle portion at a proximal portion of the deviceincluding a movable handle, an elongated portion extending distally fromthe handle portion, a first jaw and a second jaw at a distal portion ofthe device. At least one of the jaws is movable toward the other jaw totransition the first and second jaws from an open configuration to aclosed configuration. A fastener supporting member of a surgical implantis supported in the first jaw and the fastener supporting membersupports a plurality of fasteners. A fastener receiver member of thesurgical implant is supported in the second jaw. A drive assembly isactuable by the movable handle to transition the first and second jawsbetween the open and closed configurations and to advance the pluralityof fasteners in a first direction into engagement with the fastenerreceiver member to couple the fastener supporting member and fastenerreceiver member. A release is operatively associated with the movablehandle. The movable handle is movable from a first position to a secondposition to transition the jaws to the closed configuration, the movablehandle locked in the second position and the release actuable to releasethe movable handle to enable movement back to the first position.

According to another embodiment, a surgical device is providedcomprising a handle portion at a proximal portion of the deviceincluding a movable handle, an elongated portion extending distally fromthe handle portion, and a first jaw and a second jaw at a distal portionof the device. At least one of the jaws is movable toward the other jawto transition the first and second jaws from an open configuration to aclosed configuration. A plurality of surgical fasteners are supported inthe first jaw. A drive assembly is movable from a proximal position to adistal position to advance the plurality of fasteners from the first jawtoward the second jaw, the movable handle operatively associated withthe drive assembly, wherein the movable handle is actuable to transitionthe first and second jaws from the open configuration to the closedconfiguration and to advance the driver to advance the plurality offasteners. A release is operatively associated with the movable handleand has a first release position enabling movement of the movable handleto transition the jaws from the closed configuration back to the openconfiguration and has a second release position enabling the movablehandle to effect advancement of the drive assembly to advance theplurality of fasteners.

In some embodiments, the drive assembly is movable in distal andproximal directions, wherein distal movement of the drive assemblyadvances the plurality of fasteners and proximal movement of the driveassembly further advances at least one of the plurality of fasteners.The device may further include a first tensioning member connected tothe drive assembly and a second tensioning member connected to the driveassembly, wherein the first tensioning member moves the drive memberdistally in the first direction and the second tensioning member movesthe drive member proximally in the second direction, and the firsttensioning member extends from a first drive spool and the secondtensioning member extends from a second drive spool.

In some embodiments, upon movement of the release to the first position,further actuation of the movable handle to effect advancement of thedrive assembly is blocked. In some embodiments, wherein upon movement ofthe release to the second position, the jaws cannot be transitioned tothe open configuration until the plurality of fasteners are advanced. Insome embodiments, the movable handle is pivotable toward a stationaryhandle and a hook is positioned between the movable handle and thestationary handle which locks the movable handle. In some embodiments,the release is actuable by a button positioned on the movable handle.

BRIEF DESCRIPTION OF THE DRAWINGS

The following descriptions should not be considered limiting in any way.With reference to the accompanying drawings, like elements are numberedalike:

FIG. 1 is a perspective view of an implant according to an exampleembodiment;

FIG. 2 is a perspective view of the opposite side of the implantillustrated in FIG. 1;

FIG. 3 is a sectional exploded view of a segment of the implant of FIG.1,

FIG. 4 is a side elevation view of the exploded section shown in FIG. 3;

FIG. 5 is a perspective view of the exploded section shown in FIGS. 3and 4;

FIG. 6 is a perspective view of the exploded section shown in FIGS. 3and 4, showing the underside of the perspective shown in FIG. 5;

FIG. 7A is a perspective view of a retainer of the implant of FIG. 1,

FIG. 7B is an overhead view of a retainer according to an exampleembodiment of the present disclosure;

FIG. 8 is a partial view of a tip portion of a fastener of the implantof FIG. 1;

FIG. 9 is a perspective view of a section of the implant of FIG. 1engaging a relatively thin structure;

FIG. 10A is a side view of the implant of FIG. 9 engaging the relativelythin structure;

FIG. 10B is another side view of the implant of FIG. 9 engaging therelatively thin structure;

FIG. 10C is another side view of the implant of FIG. 9 showing theimplant engaging the relatively thin structure, with barbs catching orotherwise engaging a retainer;

FIG. 11 is a perspective view showing the tips of the legs of theimplant illustrated in FIG. 9 catching on or otherwise engaging theretainer, with portions of the implant removed for clarity, the viewrotated with respect to the orientation of FIG. 9;

FIG. 12 is a perspective view of a section of the implant of FIG. 1engaging a relatively thick structure;

FIG. 13A is a side view of the implant of FIG. 9 engaging the relativelythick structure.

FIG. 13B is another side view of the implant of FIG. 9 engaging therelatively thin structure.

FIG. 13C is another side view of the implant of FIG. 9 showing theimplant engaging the relatively thick structure, with barbs catching orotherwise engaging a retainer.

FIG. 14 is a perspective view showing the tips of the legs of theimplant illustrated in FIG. 9 catching on or otherwise engaging theretainer, with portions of the implant removed for clarity, the viewrotated with respect to the orientation of FIG. 9;

FIG. 15 is a perspective view of a fastener according to an examplealternative embodiment;

FIG. 16A is a top view of the section of an implant according to anexample embodiment;

FIG. 16B shows a sectional view taken through section line 64 of FIG.16A.

FIG. 17A shows a tower of the implant under compression, according to anexample embodiment;

FIG. 17B shows a photo similar to the embodiment of FIG. 17B;

FIG. 18 is a top view of an implant according to an example embodiment,showing the implant configured in a curved array such as a circulararray;

FIG. 19 is a top view of an implant according to an example embodiment,showing the implant configured in an arcuate or curved array, such as apartial circular array;

FIGS. 20 through 26 show perspective views of various retainerconstructions, according to various example embodiments;

FIG. 27A is a perspective view of an implant placed about a tissue orvessel structure according to an example embodiment;

FIG. 27B is a perspective view of the implant shown in FIG. 27A from theopposing side;

FIG. 27C is a perspective view of the implant placed about a tissue orvessel structure according to another example embodiment;

FIG. 27D is an end view of the implant of FIG. 27C;

FIG. 27B is a cut-away perspective view of the implant of FIG. 27C;

FIG. 27F is a close up view of the implant of FIG. 27E (with the vesselnot shown);

FIG. 27G is a close up view of an alternate embodiment of the towers ofthe implant;

FIG. 28 is a perspective view of an implant placed about a tissue orvessel structure according to an example embodiment;

FIG. 29 shows a cross-sectional view of the implant taken about sectionline 29-29 in FIG. 27A;

FIG. 30A shows a cross-sectional view of the implant taken about sectionline 30A-30A in FIG. 27A;

FIG. 30B shows a cross-sectional view of the implant taken about sectionline 30B-30B in FIG. 27A;

FIG. 31 shows a cross-sectional view of the implant taken about sectionline 31-31 in FIG. 27A;

FIG. 32 is a perspective view of two single row implants placed about atissue or vessel structure according to an example embodiment;

FIG. 33 is a perspective view of a single row implant placed about atissue or vessel structure according to another example embodiment;

FIG. 34 schematically illustrates a side-to-side connection for ananastomosis formed by an implant according to one embodiment disclosedherein;

FIG. 35 is an enlarged view of the area indicated in FIG. 34;

FIG. 36 is an elevation view of a flat-formed fastener of the implantaccording to an example embodiment;

FIG. 37 is a perspective view of the fastener of FIG. 36;

FIG. 38 is a perspective view of the fastener of FIG. 36 in a bentconfiguration,

FIG. 39 is a top view of the fastener of FIG. 38;

FIG. 40 is a side view of the fastener of FIG. 38;

FIG. 41 is a sectional view taken about section line 41-41 of FIG. 38;

FIG. 42 is a sectional view taken about section line 42-42 of FIG. 38;

FIG. 43A is a top view of a strip of formed fasteners according to anexample embodiment;

FIG. 43B is a detail view taken about border 150 of FIG. 43A;

FIG. 44A is a perspective view of a fastener of an implant according toan alternate embodiment disclosed herein;

FIG. 44B is a side view of the leg of the fastener of FIG. 44A;

FIG. 44C is a side view of the leg of a fastener of an implant accordingto an alternate embodiment disclosed herein;

FIG. 44D is a transverse view of the fastener of FIG. 44C fullycontained within the implant prior to firing;

FIG. 44E is a longitudinal sectional view of a portion of the implantshowing one of the fasteners of FIG. 44D advanced through the deploymentmember and other fasteners not yet advanced;

FIG. 44F is a top view of a strip of the formed fasteners of FIG. 44A;

FIG. 44G is a perspective view of the strip of fasteners of FIG. 44Ebent to form U-shaped fasteners;

FIG. 45 is a schematic sectional elevation view of a fastener systemaccording to an example embodiment;

FIG. 46 shows a schematic sectional elevation view of a fastener systemaccording to an alternate example embodiment;

FIG. 47 shows a schematic sectional elevation view of a fastener systemaccording to another alternate example embodiment;

FIG. 48A shows a side elevation of a fastener having a corkscrew-likeconfiguration according to an alternate embodiment disclosed herein;

FIG. 48B shows a side elevation of a fastener having a screw-likeconfiguration according to an alternate embodiment disclosed herein;

FIG. 49 shows an elevation view of a fastener of another exampleembodiment;

FIG. 50 is an isometric view of a system having an implant and anapplicator, according to an embodiment of the present disclosure;

FIG. 51A is an isometric view of the system of FIG. 50 having a portionof a housing removed to illustrate components of a driving assembly inan initial position, the applicator jaws shown in open configuration;

FIG. 51B is a side view of the system shown in FIG. 51A;

FIG. 51C is a detail view of the portion of FIG. 51A within circularborder C of FIG. 51A;

FIG. 51D is a partial side view of a portion of the system of FIG. 51C;

FIG. 52A is an isometric view of the system of FIG. 50, showing the jawsrotated and articulated;

FIG. 52B is a side view of the system shown in FIG. 52A;

FIG. 52C is a detail view of the portion of FIG. 52A within circularborder C of FIG. 52A;

FIG. 52D is a cross-sectional view of the positioning assembly of FIG.52A;

FIG. 52E is a perspective view of an alternate embodiment of anarticulation mechanism of the present disclosure;

FIG. 52F is a perspective view of the other side of the articulationmechanism of FIG. 52E;

FIG. 52G is a perspective view of the articulation mechanism of FIG. 52Earticulated to a pitch down position;

FIG. 52H is a perspective view of the articulation mechanism of FIG. 52Earticulated to a pitch up position;

FIG. 52I is a perspective view of the articulation mechanism of FIG. 52Earticulated to a yaw right position;

FIG. 52J is a perspective view of the articulation mechanism of FIG. 52Earticulated to a yaw left position;

FIG. 52K is a perspective view of the articulation mechanism of FIG. 52Earticulated simultaneously to a pitch up and yaw left position;

FIG. 52L is a side view showing the end effector articulated to thepitch up position corresponding to the position of FIG. 52H;

FIG. 52M is a side view showing the end effector articulated to thepitch down position corresponding to the position of FIG. 52G;

FIG. 53A is a perspective view of a lower jaw and a joint of the systemof FIG. 50;

FIG. 53B is a view of a bottom of the lower jaw of FIG. 53A;

FIG. 54A is a perspective view of a set of jaws of the applicator of thesystem of FIG. 50 in an open configuration;

FIG. 54B is a partial, enlarged view of a proximal portion of thestationary jaw of FIG. 54A;

FIG. 54C is a partial, enlarged view of a proximal portion of thestationary jaw of FIG. 54A;

FIG. 55A is a partial, enlarged view of a distal portion of the jaw ofFIG. 54A;

FIG. 55B is a perspective view of the jaws of FIG. 54A in a closedconfiguration;

FIG. 55C is a detail view of the portion of FIG. 55B within the circularborder C of FIG. 55B;

FIG. 55D is a partial, enlarged view of a proximal portion of analternate embodiment of the stationary jaw;

FIG. 55E is a partial, enlarged view of the stationary and movable jawsshown in the opposite orientation of FIG. 55D;

FIG. 55F is an enlarged view of a portion of the stationary jaw of FIG.55D showing the driver and the channels for the driver,

FIG. 55G is an enlarged view of a portion of the stationary jaw of FIG.55D showing the driver, channels for the driver, and some of thefasteners;

FIG. 55H is an enlarged cut away view showing the channels for thedriver and some of the fasteners of FIG. 55G;

FIG. 55I is a perspective view of the movable jaw and stationary jawhaving the driver of FIG. 55D, the jaws shown in the closedconfiguration;

FIG. 55J is a perspective view of a portion of the stationary jaw ofFIG. 55D showing the driver partially advanced to deploy some of thefasteners;

FIG. 55K is a side view in the orientation opposite FIG. 55J showing thedriver partially advanced to deploy some of the fasteners;

FIG. 56A is a side view of the jaws of FIG. 54a in the openconfiguration;

FIG. 56B is a cross-sectional view of the jaws taken generally alongsectional line B-B of FIG. 56A;

FIG. 57A is a perspective view of a driving mechanism for the applicatorof FIG. 50 according to an embodiment disclosed herein;

FIG. 57B is a perspective view of a trigger and a pair of ratchetassemblies for the applicator of FIG. 50 according to an embodimentdisclosed herein;

FIG. 57C is an enlarged view of the trigger and ratchet assembliesportion of FIG. 57A within the circle C;

FIG. 57D is a side view of an internal portion of a housing of theapplicator of FIG. 50;

FIG. 57E is a partial, cross-sectional view taken though the housing anda portion of the driving mechanism of the applicator of FIG. 50;

FIG. 58A is an isometric view of the system of FIG. 50 having a portionof a housing removed to illustrate components of the driving assembly,the applicator shown in an intermediate position to move the jaws to theclosed configuration;

FIG. 58B is a side view of the system shown in FIG. 58A;

FIG. 58C is a detail view of the portion of FIG. 58A within circularborder B of FIG. 58A;

FIG. 581) is a partial side view of a portion of the system of FIG. 58C;

FIG. 59A is an isometric view of the system of FIG. 50 having a portionof a housing removed to illustrate components of the driving assembly,the applicator shown in the fully actuated position to advance thefasteners from the jaws;

FIG. 59B is a side view of the system shown in FIG. 59A;

FIG. 59C is a detail view of the portion of FIG. 59A within circularborder B of FIG. 59A;

FIG. 59D is a partial side view of a portion of the system of FIG. 59C;

FIG. 60A is an isometric view of the system of FIG. 50 having a portionof a housing removed to illustrate components of a driving assembly;

FIG. 60B is a side view of the system shown in FIG. 60A;

FIG. 60C is an enlarged view of the portion of FIG. 60A within circle C;

FIG. 60D is a partial side view of a portion of the system of FIG. 60C;

FIG. 60E is a side view of a handle portion having a handle releasemechanism in accordance with another embodiment, the handle shown in theinitial jaws open position;

FIG. 60F is a side view similar to FIG. 60E showing the movable handlein the jaws closed position;

FIG. 60G is a side view similar to FIG. 60F showing the movable handlein the jaws closed position and the safety button partially pressed;

FIG. 60H is a side view similar to FIG. 60G showing the handle in thejaws closed position and the safety button fully pressed;

FIG. 60I is a side view similar to FIG. 60H showing the handle sprung tothe jaws open position for commencement of the ratcheting cycle to firethe fasteners;

FIG. 60J is a side view similar to FIG. 60I showing the handle pulled tocommence the cycle to fire the fasteners;

FIG. 60K is an enlarged perspective view of a portion of the handle ofFIG. 60E showing the ratchet wheel engagement;

FIG. 60L is an enlarged perspective view of a portion of the handle ofFIG. 60E showing the interaction of the handle catch and ratchet wheelridge;

FIG. 61A is a perspective view of one embodiment of a loading assemblyfor the jaws of the applicator of FIG. 50;

FIG. 61B is a bottom view of the loading assembly of FIG. 61A;

FIG. 61C is a cross-sectional view of the loading assembly of FIG. 61Btaken generally along line C-C;

FIG. 62A is a perspective view illustrating two implants being installedby the jaws of the applicator of FIG. 50 in a head-to-tail arrangement;

FIG. 62B is a perspective side view illustrating an angled gap forassisting in the head-to-tail arrangement of FIG. 62A;

FIG. 62C is a perspective view of the jaws of FIG. 50 in an openconfiguration;

FIG. 62D is an enlarged view of the portion of FIG. 62D within circle D;

FIGS. 63A-63E schematically illustrate a method of installing twoimplants in a head-to-tail arrangement;

FIG. 64 is a perspective view of an implant according to an alternateembodiment installed on a representative tissue structure;

FIG. 65 is an enlarged view of a pin/fastener of the implant of FIG. 64extending through the representative tissue structure;

FIG. 66 is an enlarged perspective view of a portion of the implant ofFIG. 64, showing the fastener extending into the receiver;

FIG. 67 is a perspective view of a fastener of an implant according toan alternate embodiment disclosed herein;

FIG. 68 is a perspective view of a fastener of an implant according toanother alternate embodiment disclosed herein;

FIG. 69 is a perspective view of a surgical instrument having a set ofjaws in an open configuration for positioning the implant of FIG. 64with respect to the representative tissue structure;

FIG. 70 is a perspective view of the surgical instrument of FIG. 69 withthe jaws in a closed position;

FIG. 71 is a perspective view of a proximal end of the jaws of FIG. 69showing a driver for applying the implant to the tissue structure;

FIG. 72 is a perspective view of a distal end of the jaws of FIG. 70after the driver of FIG. 71 has applied the implant;

FIG. 73 is a perspective view of a pair of the implants of FIG. 64installed on the representative tissue sample with a cut made betweenthe implants;

FIG. 74 is a perspective view of the representative tissue structure ofFIG. 73 after the cut is made and one half of the tissue structure isremoved;

FIG. 75 is a perspective view of the implant of FIG. 64 installed on asmaller tissue structure and with the ends of the implant cropped;

FIG. 76 is an end view illustrating a minimal profile of the instrumentof FIG. 69 with the implant of FIG. 64;

FIG. 77 is a perspective view of an implant according to an alternateembodiment having a first half or member connected to a second half ormember via a hinge;

FIG. 78A is a perspective view of an alternate embodiment of an endeffector, the jaws shown in the open position;

FIG. 78B is a perspective view similar to FIG. 78A showing the jaws inthe closed position;

FIG. 79 is enlarged view of a proximal portion of the jaws of FIG. 78B(in the closed position);

FIG. 80A is an enlarged cut away view of the jaws of FIG. 79 takenthrough the protrusion/opening engagement of the jaws;

FIG. 80B is an enlarged view showing the proximal end of the movable jawof FIG. 78A;

FIG. 80C is an enlarged view of a proximal portion of the stationary jawof FIG. 78A;

FIG. 81A is a side view of the jaws of FIG. 78A showing schematicallythe pull force for effecting initial closure of the jaws;

FIG. 81B is a side view similar to FIG. 81A showing the jaws in theclosed position;

FIG. 81C is a side view of the jaws of 81A showing schematically thepull force to effect jaw closure during deployment of the fasteners;

FIG. 81D is a side view similar to FIG. 81C showing the jaws in theclosed position;

FIG. 82A is a side view of the end effector assembly of FIG. 78A showingthe cam path of the driver tab,

FIG. 82B is an enlarged view of the distal end of the end effectorassembly of FIG. 82A;

FIG. 83A is a perspective view of the end effector assembly of FIG. 82Ashowing the jaws in the open position prior to initial advancement ofthe driver assembly;

FIG. 83B is a perspective view of the end effector assembly of FIG. 83Ain the opposite orientation;

FIG. 83C is a side view of the end effector assembly of FIG. 83A;

FIG. 84A is a perspective view of the end effector assembly of FIG. 82Ashowing the jaws in the closed position upon initial advancement of thedriver assembly;

FIG. 84B is a perspective view of the end effector assembly of FIG. 84Ain the opposite orientation;

FIG. 84C is a side view of the end effector assembly of FIG. 84A;

FIG. 85A is a perspective view of the end effector assembly of FIG. 82Ashowing the jaws in the closed position and the driver assembly moved toits distal position;

FIG. 85B is a perspective view of the end effector assembly of FIG. 85Ain the opposite orientation;

FIG. 85C is a side view of the end effector assembly of FIG. 85A;

FIG. 85D is an enlarged perspective view of a distal portion of the endeffector assembly of FIG. 82A showing the driver tab advanced toward adistal position;

FIG. 85E is an enlarged perspective view similar to FIG. 85D showing thedriver tab in its distal position;

FIG. 85F is an enlarged perspective of a distal portion of the endeffector assembly of FIG. 82A showing the driver advanced toward itsdistal position;

FIG. 86A is a perspective view of the end effector assembly of FIG. 82Ashowing the driver assembly moved to a second position to enable thejaws to slightly open;

FIG. 86B is a perspective view of the end effector assembly of FIG. 86Ain the opposite orientation;

FIG. 86C is a side view of the end effector assembly of FIG. 86A;

FIG. 87A is a perspective view of the end effector assembly of FIG. 82Ashowing the jaws slightly opened as the driver assembly retracts;

FIG. 87B is a perspective view of the end effector assembly of FIG. 87Ain the opposite orientation;

FIG. 87C is a side view of the end effector assembly of FIG. 87A;

FIG. 88A is a perspective view of the end effector assembly of FIG. 82Ashowing the jaws in the open position as the driver assembly is moved toits proximal position;

FIG. 88B is a perspective view of the end effector assembly of FIG. 88Ain the opposite orientation;

FIG. 88C is a side view of the end effector assembly of FIG. 88A;

FIG. 89A is a perspective view of one embodiment of a loading assembly;

FIG. 89B is a perspective view of the loading assembly of FIG. 89Ashowing the other side;

FIG. 89C is cutaway view of the loading assembly of FIG. 89A;

FIG. 90 is a side view of the loading assembly of FIG. 89A being placedin the open jaws of a surgical applicator;

FIG. 91A is an enlarged perspective view showing engagement of theloading assembly of FIG. 89A with the tab of the movable jaw;

FIG. 91B is an enlarged perspective view showing the proximal end of thecartridge portion of the loading assembly of FIG. 89A engaged with thetab of the movable jaw as the loading assembly is rotated into themovable jaw;

FIG. 92 is a side view similar to FIG. 90 showing the loading assemblyrotated and snapped into the movable jaw;

FIG. 93A is an enlarged view of a portion of the loading assembly andthe jaws showing the reload assembly snapped into the moving jaw;

FIG. 93B is a cutaway view showing the cartridge portion snapped intothe movable jaw;

FIG. 94 is a side view similar to FIG. 92 showing the jaws in the closedposition;

FIG. 95A is a side view similar to FIG. 94 showing the jaws in theclosed position and the loading assembly being slid out from the jaws;

FIG. 95B is a cutaway view showing the receiver member frictionallyengaged with the stationary jaw;

FIG. 96 is a side view showing the jaws in the open position with theimplant loaded in the movable and stationary jaws; and

FIGS. 97A through 97D relate to packaging options for one or moreloading assemblies as described throughout the present disclosure.

DETAILED DESCRIPTION

A detailed description of one or more embodiments of the disclosedapparatus, implant and method are presented herein by way ofexemplification and not limitation with reference to the Figures.

Various embodiments of surgical implants and tools (apparatus) forinstalling such implants are described below and illustrated throughoutthe drawings. For purposes of the description hereinafter, the words“upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,”“bottom,” “lateral,” “longitudinal,” “axial,” and like terms, if used,shall relate to the apparatus and/or implant, as it is oriented in thedrawing figures. When appropriate, the terms “proximal” and “distal” arein reference to a user that uses the tool to deploy the implant,typically towards a portion of a patient's anatomy. The term “distal”shall for instance mean situated further away from the user, while theterm “proximal” shall mean situated more towards the user. The phrases“installing/installed on”, “installing/installed about”,“installing/installed through”, and other similar phrases are generallyintended to be interchangeable and refer to an implant being used tosecure, connect, seal, clamp, compress, and/or fasten various tissue andnon-tissue structures, including those internal to a mammalian bodycavity as well as those external (e.g., postpartum umbilical cord). Theterm “surgical structure” as used herein refers to any tissue ornon-tissue structure on which an implant is, is to be, or is intended ordesired to be secured. The terms “seal”, “sealed” “sealing”, etc., asused herein refer to slowing, hindering, blocking, and/or otherwiseimpeding the flow of fluid through, by, past, beyond, or betweensurgical structures on which an implant is installed. As used herein,the terms “ventrum” and “ventral side” refers to the side of a component(e.g., part of an implant or a tool for installing an implant) thatgenerally faces toward, or abuts, the surgical structure. “Ventrally”likewise refers to the direction generally toward the surgicalstructure. Oppositely, the terms “dorsum” and “dorsal side” refer to theside opposite from the ventrum, i.e., the side generally facing awayfrom the surgical structure. Likewise, “dorsally” refers to thedirection generally away from the surgical structure.

Referring now to FIGS. 1-2, a surgical implant 10 in accordance with anembodiment is illustrated. The implant 10 is shown to be elongate suchthat its length exceeds its width, and in the present example isillustrated to include two halves or parts configured to be broughttogether. In certain embodiments, one of the halves is a receiver member12 to receive fasteners and the other is a deployment member 14, alsoreferred to herein as a fastener retaining member, fastener supportingmember, or fastener carrying member, which supports the fasteners. Inother embodiments, features of either of the receiver member 12 and thedeployment member 14 can be included instead in the other. For example,each half may include both receiver members 12 and deployment members14. In certain embodiments the halves are connected in at least onelocation, either directly or indirectly prior to use and/or activation,while in other embodiments the halves are not connected prior to useand/or activation. As discussed in more detail below, the members 12 and14 are to be positioned on opposite sides of one or more surgicalstructures such as tissue, a non-tissue structure, or a tissue structurein combination with a non-tissue structure. The members 12 and 14 arethen secured (coupled) together in order to clamp or compress thesurgical structure(s) therebetween. As in one example, by clamping orcompressing tissue between the members 12 and 14 and holding the tissuein this clamped or compressed state, fluid flow through the tissue ortissue-to-tissue interface can be sealed. In other embodiments, varioustissue and/or non-tissue structures (including simulated or artificialtissue structures) may be secured together by the implant 10, with orwithout the aforementioned sealing.

Examples of tissue structures include, but are not limited to, bloodvessels such as the aorta, superior vena cava, inferior vena cava, lobarvessels, the renal artery, organ parenchyma including pulmonaryparenchyma, bronchii, lobar bronchi, trachea, atrial appendages,gastrointestinal structures, colon, spleen, liver tissue, etc. Theimplant 10 can be useful for establishing hemostasis, pneumostasis, orto seal off the flow of other fluids through various other tissuestructures within a patient, as well as to connect these tissues andother tissue and non-tissue structures together with or without fluidsealing. Examples of non-tissue structures include PTFE, ePTFE, grafts,stents, textile weaves, braids, and knits, meshes, plugs,gastro-intestinal sleeves, etc. In each of the disclosed embodiments,when the implant 10 is located about two or more structures, thestructures may be either the same (e.g., vessel tissue to vessel tissue,bronchii tissue to bronchii tissue, non-tissue to non-tissue, etc.) ordifferent (e.g., bronchii tissue to non-bronchii tissue (including forinstance PTFE), gastrointestinal tissue to non-gastrointestinal tissueor structures such as textile or PTFE sleeves, etc.).

In an exemplary embodiment, the receiver member 12 includes a receiverbase 16 having a surgical structure contacting surface 18 located at oneside thereof, which may be referred to herein as its ventrum or ventralside. As can be seen, for example in FIG. 1, the receiver member 12 isformed of an essentially repeating pattern of segments 20, with each ofthe segments 20 including a shield or roof 22 extending dorsally from aportion of the receiver base 16 in proximity to each of the shields 22.As shown, the shields 22 are arranged along rows substantially parallelto a longitudinal axis of the receiver member 12 positioned opposite thefasteners 32 to shield the penetrating tips of the fasteners 32 asdescribed below. Similarly, the deployment member 14 includes a base 24having a surgical structure contacting surface 26 along its ventrum.Contained within the base 16 is a retainer discussed in more detailbelow. The surgical structure contacting surfaces 18 and 26 aregenerally arranged to face each other and to be contacted againstopposite sides of a surgical structure or multiple adjacent surgicalstructures in order to clamp, secure or compress the structure betweenthe oppositely positioned surgical structure contacting surfaces andprovide the aforementioned sealing, securing, and/or fastening functionsof the implant 10. The deployment member 14 is formed from a pluralityof segments 28, which correspondingly repeat with respect to thesegments 20 along the length of the implant 10.

Each of the segments 28 is shown to include a resilient and/orcompressible member, suspension, spring, or biasing element, representedgenerally as a tower 30 (or tower-like structure) extending dorsallyfrom the base 24 in a direction substantially perpendicular to the base24 of the fastener supporting member 14 and a clip, anchor, or fastener32 disposed with each of the towers 30. As shown, the fastener 32straddles a respective tower 30 so the base of the fastener 32 exerts aforce against the base of the tower 30 when deployed to compress anddeform the tower 30. As described in more detail below, each tower 30 iscompressible in accordance with the distance of advancement of thefastener engageable with the tower, and the distance of advancement isdependent on a thickness of tissue or other surgical structure clampedbetween tissue contacting surfaces of the receiver member 12 anddeployment member 14, through which the fasteners 32 advance. Thesegments 20 and 28 are preferably arranged in pairs, with each pair ofsegments 20 and 28 forming a fastener subassembly 34. It is to beappreciated that any number of the subassemblies 34 can be repeated ineither patterns or randomized series in order to form the implant 10 ina variety of differently sizes and/or shapes to accommodate a variety ofdifferent tissue types, geometries, sizes, and shapes. For example, thenumber of the subassemblies 34 can be increased or decreased in order tochange the length of the implant 10. For example, in one embodiment, animplant may be formed as a single one of the subassemblies 34 and usedfor tacking or securing surgical structures together. In anotherembodiment, an implant includes a single one of the subessemblies 34 andis used for tacking a hernia mesh to an underlying muscle tissuestructure. Additionally, it is noted that if the implant 10 is longerthan necessary or desired than the length required to complete a task(e.g., the implant 10 exceeds the width of the surgical structure), anyexcess ones of the subassemblies 34 (i.e., those that do not have anytissue positioned between the members 12 and 14) can be cut or trimmedoff as desired. Unlike staples, which may be left behind in great numberinside of a patient, the aforementioned approach can be used, forexample, to limit the amount of excess material left within a patientafter a surgical procedure. It is also noted that multiples of theimplant 10 can be installed sequentially, e.g., in a head-to-tail ortail-to-head sequence. For example, it some situations it may beunfeasible or undesirable to manufacture, install, or handleextraordinarily long implants (e.g., having dozens of the subassemblies34), so multiple shorter implants may be used instead and may beinstalled in series. As another example, it may be desirable to installimplants along a non-linear path, and thus multiples of the implant 10may be installed in series, but at angles with respect to each other. Asone example, the implants 10 may be installed in this sequential orhead-to-tail arrangement during a lung resection procedure, which mayrequire both a relatively long and non-linear section of tissue to besealed.

The subassemblies 34 in the illustrated embodiment as shown for examplein FIGS. 1-2 are arranged in two substantially identical and parallelrows 35 a and 35 b (collectively, “the rows 35”), connected by a bridge37. The rows 35 form a channel, guide, or pathway in order to facilitatethe cutting of the surgical structure located between the rows 35 afterinstallation of the implant 10, as discussed in more detail below. Onerow (e.g., FIG. 33), as well as more than two rows (not shown), are bothadditionally contemplated in various embodiments.

One of the fastener subassemblies 34 is shown according to oneembodiment in more detail in the exploded views of FIGS. 3-6. In theillustrated embodiment, the fasteners 32 each include a pair of shanks,pins, or legs 36 extending from base or body 38 that straddle theircorresponding towers 30 and extend ventrally from a body 38 of thefasteners 32. Each of the legs 36 may terminate in a penetrating tip 40that is configured to pierce through whatever surgical structure islocated between the receiver and deployment portions 12 and 14,including but not limited to human tissue. Initially, the tips 40 may beembedded completely within the base 24, or protrude partially outthrough the surgical structure contacting surface 26 of the base 24. Thelegs 36 may have a barbed or hooked region located at or proximally withrespect to the tip 40. In the illustrated embodiment, each of the tips40 includes two hooks or barbs 42 a and 42 b (collectively, “the barbs42”), positioned on opposite sides of the leg 36. In one embodiment, thebarbs 42 are offset from each other along the length of the legs 36,e.g., with the barb 42 a being located further along the length (furtherfrom the base or body 38) of each leg 36 than the barb 42 b. Oneadvantage of such an offset is to facilitate the accommodation ofdifferent tissue thicknesses, even across the same tissue structure. Inother embodiments the barbs can be aligned rather than offset. It is tobe appreciated that in other embodiments contemplated herein, one of thefasteners 32 may be formed with only a single leg, or more than twolegs, which extend from the body 38. Additionally, in other contemplatedembodiments, one of the legs 36 may include a single barb or hook 42, ormore than two such barbs or hooks positioned at various locations alongthe length of their corresponding legs 36. The legs 36 are shownextending substantially perpendicular from the base but alternativelycan extend at acute or obtuse angles from the base 38.

During installation of the implant 10 on or about a structure, thefasteners 32 are driven or actuated toward the towers 30 against areactionary resilient force exerted by the towers 30. Forces applied tothe fastener 32 therefore compress (and deform) the towers 30 toward thebase 24 or deployment member 14 as the base of the fasteners 32 engagesthe base of towers 30 to apply a force thereto to compress and deformthe respective towers 30 so the towers 30 move from a firstconfiguration to a second configuration. Actuation of the fastenersresults in the tips 40 of the fasteners 32 being driven out from thebase 24 of the deployment member 14, through any surgical structure onwhich the implant 10 is installed, and into the receiver base 16 of thereceiver member 12. In various embodiments, the receiver base 16 mayinclude a retainer 44 disposed therewith, e.g., disposed on and/orembedded therein as shown throughout the Figures. A representativeportion of the retainer 44 (with the bases 16 and 24 removed forclarity) is shown schematically in FIGS. 7A and 7B, of which FIG. 7Bshows a retainer embodiment fabricated in an interlaced manner. Thefasteners 32 may be driven with sufficient force to compress the towers30 and any structures between the structure contacting surfaces 18 and26 of the members 12 and 14, to the point at which the tips 40 passthrough or by the retainer 44. The retainer 44 is arranged with respectto the tips 40 to enable the barbs 42 to move relative to the retainer44 in one direction, i.e., the actuation direction for the tips 40(which is initially towards the ventrum, i.e., the ventral directionwith respect to the deployment member), but becomes the dorsal direction(with respect to the receiving member) after the tips 40 have passedthrough the surgical structure), but for one or more of the barbs 42 toengage with, catch, and/or otherwise grab the retainer 44 to prevent orlimit movement thereof in the opposite direction. The base 24 can alsoinclude a retainer embedded therein, e.g., in order to help strengthen,or add stiffness and/or rigidity to the member 14 as well as to retainthe fasteners 32 in their initial, unfired configuration via similarengagement with the barbs 42. Such retainer supported/positioned in base14 can be the same as the retainer 44, or its variants, describedherein.

In various embodiments, the tips 40 may protrude through the opposite(i.e., dorsal) side of the base 16 from the surgical structurecontacting (i.e., ventrally located) surface 18 when engaged with theretainer 44. As shown in the Figures, one or more shields 22, eachhaving one or more cavities or pockets 45 that receive the tip(s) 40when the tips 40 are so protruding, are positioned opposite thefasteners 32 and are generally aligned with the legs 36 of the fasteners32. In this way, the shields 22 can provide protection from the tips 40,e.g., protection to shield from inadvertent contact of the tips 40 by amedical professional or other tissue structures within the patient ifthe implant 10 is to be left inside of the patient. In one embodiment,the shields 22 do not include the pockets 45, such that the tips 30 arecompletely surrounded by and embedded within the shields 22.

In the illustrated embodiment, the retainer 44 includes longitudinal orlengthwise strands 46 a and transverse or widthwise strands 46 b(collectively “the strands 46”) with a plurality of interstices oropenings 48 formed by spacing between the plurality of strands. It is tobe understood that the strands 46 generally represent any wire, bar,cord, slat, strut, spoke, fiber, thread, tine, filament, cable, or otherelongated element. In one embodiment, the retainer 44 is a woven,knitted, or braided mesh, or other grid-like structure. In oneembodiment, the strands 46 are arranged in a random or irregularpattern, such as a felt, or a non-woven pattern, such as TYVEK brandmaterial made commercial available by DuPont. The strands 46 a may beseparate from each other and/or separate from the strands 46 b.Alternatively, the strands 46 may be integrally formed, fused, oraffixed together. In FIG. 7B, the stands are interlaced with alternatingoverlapping portions and with interstices 48 between the strands. It isfurther understood that in some embodiments, strands can exist in afirst direction only. The first direction in some embodiments may begenerally along the lengthwise (i.e., longitudinal) direction of theimplant 10, and in other embodiments it may be the transverse directionalong the width. In embodiments in which the length of the implant 10 issignificantly larger than its width, similar to the illustratedembodiments of FIG. 1, it may be desired for the barbs 42 to be alignedto catch and engage with the longitudinal strands 46 a, as these strandsshare a greater contact area with the material of the bases 16 and/or 24than the transverse strands 46 b, and thus are more likely have asufficient degree of interference or friction with the bases towithstand the relatively high loading that may be required for somesurgical structures, e.g., particularly thick structures, without damageto the implant 10 or loss of function. Other embodiments arecontemplated wherein additional features are included with the strandssuch as anchors to enhance the interference or friction with the bases.

In various embodiments, the towers 30 are integral to or unitary withthe base 24, while it is contemplated in other embodiments that towersmay be formed separately from the base. The towers 30 are configuredwith a structural shape and of a material that allows for a suitabledegree of compressibility, such that when force is exerted on the towers30 towards the base 24 (i.e., ventrally) by the base 38 of the fasteners32, either directly or indirectly, the strain of the towers 30 is morethan any strain encountered by the base 24. The towers 30 may be formedof a resilient material, such that upon removing the actuation forcefrom the fasteners 32, the towers 30 attempt to revert back to theiroriginal shapes and exert a corresponding tensile force on the fasteners32 in a direction opposite to actuation. That is, the towers 30 formbiasing or counterforce members to exert a counterforce in a directionopposite to the direction in which the fasteners 32 are deployed(advanced). In this way, the towers 30 function similarly to compressionsprings, and in fact, may be replaced or supplemented by such springs(e.g., see FIG. 49 illustrating spring 30A) or other resilient elementsin various embodiments. For example, in one embodiment the towers 30 mayeach be configured as a resilient, flexible plug made from anelastomeric material, such as silicone rubber, that protrudes upwardfrom base 24. The plug can be formed as a protrusion having any desiredgeometric configuration, including but not limited to a cylindrical,rectangular or dome structure. The towers 30 can each be operativelyassociated with one of the fasteners 32 so as to upwardly, or dorsally,bias the fastener 32 relative to the base 24. The resilient forceexerted by the towers 30 on the bodies/bases 38 of the fasteners 32causes one or more of the barbs 42, having been driven through theretainer 44 during actuation, to engage and grab one or more of thestrands 46 of the retainer 44. The upward or dorsally directed biasagainst the fastener 32 resulting from the spring and/or suspensionproperties of the tower 30, such as when the fastener 32 extends over anexterior surface of the tower 30, exerts a pull force on fastener 32 asthe barbs 42 latch on a portion of the retainer 44. In this way, thecompressed towers 30 continue to exert a force to pull the receivermember 12 toward the deployment member 14, after the receiver member 12and deployment member 14 are coupled together by the fasteners 32,thereby sandwiching, compressing, or clamping the surgical structuretherebetween. It should be appreciated that towers are in one embodimentsubstantially cylindrical and have a height exceeding its width.Circular, oval, rectangular and other cross-section configurations arealso contemplated. Additionally, the composition or configuration of thetowers can be varied to vary the force applied to the fasteners.Additionally, within each implant, towers of varying force can beprovided (e.g., different towers having different force magnitudesand/or profiles per given strain or compression).

The fastener 32 and its related components can be arranged with avariety of dimensions to allow for the system to function appropriately.For example, the maximum amount of strain allowed for a tower inaddition to the strain of each of the bases when compressed may belarger than or equal to the sum of (i) the amount of distance the barbsmust travel to reach the tissue contact surface of the deploymentmember, (ii) the thickness of the compressed surgical structure, and(iii) the amount of distance the barbs must pass through the receivermember 12 in order to extend through the structure positioned betweenthe halves of the implant 10 and latch onto the retainer member 44.

Advantageously, the resiliency and/or spring-like nature of the towers30 provides for suitable tension to be maintained between the halves ofthe implant (e.g., the members 12 and 14) to suitably handle variablepressure fluctuations that may lead to a burst condition within thestructure being secured or sealed by the implant 10. For example, if theimplant 10 is installed on a structure to provide fluid sealing, and theseal produced therefrom experiences a pressure spike, e.g., due to thepatient coughing following a lung resection procedure with the implant10, or some other event, the towers 30 are sufficiently elastic to allowfor strain, and will thus flex and/or compress to assist in absorbingexcess forces. This helps to accommodate the spike in the pressurewithout damaging the implant 10. Furthermore, even if the seal isbreached due to the pressure burst, such that fluid leaks through theseal made by the implant 10, the resiliency of the towers 30 will causethe towers 30 to continue to exert a clamping pressure between themembers 12 and 14. This will result in the implant 10 resealing thetissue or surgical structure once the pressure spike has subsided.Oppositely, known staples from known stapling techniques are notsufficiently elastic, and are highly likely to rip or tear out duringhigh pressure events, and thus be completely unable to reseal afterexperiencing a pressure spike, which may require an additional surgeryto be performed in order to re-staple the damaged area.

It is additionally noted that the forces exerted by the towers 30 on thefasteners 32, which is communicated to the surgical structure via thefasteners 32 engaging the retainer 44 in the member 12 and pulling themembers 12 and 14 toward each other, can be set in a range sufficientlyhigh to promote sealing and/or closure, while not being so high as tocause necrosis of tissue on which the implant 10 is installed. Forexample, in one embodiment, the forces exerted by the towers 30 on thefasteners 32 causes the pressure exerted on surgical structures by themembers 12 and 14 at the tissue contacting surfaces 18 and 26 to be inthe range of about 3 g/mm² to 25 g/mm², or more preferably in the rangeof about 5 g/mm² to about 15 g/mm², although other ranges can also beutilized if desired. For example, some tissue types, e.g., bronchii, maybenefit from larger pressures, e.g., 10 g/mm² and greater, while othertissue types, e.g., blood vessels, may benefit from smaller pressures,e.g., between about 5 g/mm² and 7 g/mm². It is also noted that since thetowers 30 function akin to springs, the spring constant, resiliency,stiffness, and/or rigidity of the towers 30 can be set to variably alterthe force exerted by the towers 30 depending on the amount the towers 30are compressed. Since increased compression of the towers 30 occurs wheninstalling the implant 10 on thicker structures, setting the variableforce exerted by the towers 30 can be useful, e.g., for setting a first,relatively lower pressure at relatively small thicknesses for smallerand/or more delicate structures, such as blood vessels (e.g., 5 g/mm²and 7 g/mm²), and a second, relatively greater pressure at relativelylarge thicknesses for larger and/or more robust structures, such asbronchii (e.g., 10 g/mm² or greater).

It is noted that by way of the resiliency and/or compressibility of thetowers 30, the implant 10 is able to accommodate a range of surgicalstructure thicknesses approximately equal to the compressible height ofthe towers 30 (e.g., the distance between the initial height h1 as shownfor example in FIG. 3 and the fully compressed height h3 as shown inFIG. 13A). For example, in one embodiment, the towers 30 have ancompressible height (e.g., the distance between the initial height h1and the fully compressed height h3), of approximately 0.1″ (2.54 mm),and with this single geometry are capable of accommodating acorresponding approximately 2.5 mm surgical structure thickness range(the surgical structure thickness determined after compression by anyjaws or other components of a device for installing the implant 10,e.g., those applicators described herein). For example, the 0.1″compressible height towers may be capable of sealing/closing the implant10 (that is, latching onto the retainer 44 in the receiving member 12)when there is no structure between the members 12 and 14, i.e., athickness of zero; or a surgical structure having a thickness ofapproximately 2.5 mm; or any structure having a thickness in the rangebetween zero and about 2.5 mm. Contrarily, staplers require multipledifferent staple sizes to handle different tissue thicknesses. Somemanufacturers color code their staples depending on size in order toassist in a medical professional determining the correct staple to use,depending on the thickness of the tissue to be sealed or closed, foreach specific procedure. That is, each of these staple sizes, e.g. colorcoded staple sizes, is configured to accommodate a very specific tissuesize or very small range of tissue sizes, e.g., a range of only about0.25 mm or less. In this way, it can be stated that known staples areessentially fixed thickness devices, while the implant 10 and otherimplants disclosed herein are variable thickness devices.

It is also noted that while the height of the towers 30 assists indefining the thickness range that can be accommodated, e.g., a 2.5 mmrange, the length of the legs 36 of the fasteners 32 helps to set thestart and end points for the range. For example, the length of the legs36 between the body or base 38 and the end of the tips 42 can be set tobe approximately equal to, and/or slightly shorter than the initialheight of the tower 30, such as in the illustrated embodiment. In thisway, the fasteners 32 will be able to slightly compress the towers 30and thus the tips 42 catch, latch, or grab the retainer 44 in the member12 even if there is no tissue or other surgical structures locatedbetween the members 12 and 14. In this embodiment, setting thecompressible height, e.g., h1, of the towers 30 to the aforementioned2.5 mm will set the 2.5 mm range to span between 0 (no surgicalstructure) and about 2.5 mm. Consider, as one example, increasing thelength of the legs 36 by “x” units of distance. In this embodiment, ifthere is no tissue positioned between the members 12 and 14, the tips 42would protrude through and extend past the retainer 44 by a distanceapproximately equal to “x” without compressing the towers 30 (andwithout compression, the tips 42 would not be pulled against theretainer 44 for maintaining the members 12 and 14 of the implant closedor secured together). Suitable compression of the towers 30 to engagethe tips 42 with the retainer 44 would not occur in this embodimentuntil the thickness between the members 12 and 14 is increased in anamount equal to “x”. That is, increasing the length of the legs 36 by“x” distance will shift the start and end points of the range by thisdistance “x”, but while maintaining the same magnitude for the range.For example, if the compressible height of the towers 30 is again about0.1″ (thereby enabling the implant to accommodate a 2.5 mm range), andthe amount “x” is about 1 mm, then the implant in this embodiment wouldseal from about 1 mm to about 3.5 mm (i.e., the range still having amagnitude of about 2.5 mm, but shifted up by 1 mm due to the increase inlength of the legs 36). In this way, those of ordinary skill in the artwill appreciate that by changing the compressible height of the towers30, as well as the length of the legs 36 relative to the initial heighth1 of the towers 30, both the magnitude of the range and thestarting/ending points of the range can be selected as desired and/orrequired for various procedures.

Advantageously, it would require many differently sized prior artstaples in order to accommodate this same tissue thickness range (e.g.,a 2.5 mm range) that may be handled by the presently disclosed implants.It is noted that the compressible tower height of approximately 0.1″ isone example only and that other heights may be selected. Further, thetower height may be selected such that the implant 10, with anaccompanying applicator device (e.g., such as those discussed below),are together capable of fitting within a desired cannula size, e.g., a12 mm port suitable for minimally invasive procedures. In otherembodiments, the height of the towers 30 may be increased or decreasedto change the magnitude of the range, thereby creating variable rangesof thicknesses that can be accommodated. For example, an approximately0.2″ compressible tower height may fit in a 15 mm sized cannula andaccommodate an approximately 5 mm thickness range, or an approximately0.05″ compressible tower height may accommodate an approximately 1.25 mmrange. Additionally, the length of the legs 36 relative to the initialheight of the towers 30 may be set as described above to set the startand/or ending points for the range of any given magnitude. For example,the length of the legs 36 may be increased by a distance “x” to increasethe minimum thickness that can be sealed or closed by the implant by“x”, or decrease by a distance “y” in order to decrease the minimumthickness that can be sealed or closed by the implant by “y” (down tothe minimum of 0 thickness, or no surgical structure).

In one embodiment, the bases 16 and 24 of the deployment (fastenersupporting) member 14 and receiver member 12, respectively, are made ofa relatively soft, flexible, penetratable and/or puncturable, but alsoresilient material, such as silicone rubber. This enables the tips 40 ofthe fasteners 32 to be actuated into and/or through the bases 16 and 24without significantly degrading the integrity of the implant 10. It isnoted that the bases 16 and 24 may, alternatively or additionally, bemade of one or more other biocompatible materials suitable forimplantation, such as, but not limited to, polyurethane, thermoplasticelastomer (TPE), natural rubber, latex, bio-absorbable polymers, orother polymers or elastomers. The towers 30 may also be made of anycombination of these or other materials. In one embodiment, the retainer44 is made from a relatively stronger material, such as polyethyleneterephthalate (PET), polyetheretherketone (PEEK), nylon, or otherpolymers, as well as fibrous materials such as cotton, KEVLAR brandsynthetic fibers made commercially available from DuPont, etc., in orderto lend additional strength, e.g., tensile strength, stiffness,rigidity, and/or resistance to bending, to the implant 10, as well as tosuitably engage with and retain the fasteners 32 via the barbs 42. Othermaterials for the retainer 44 include various relatively high tensilestrength polymers, as well as biocompatible metals such as stainlesssteel, titanium, nitinol, etc., although those of ordinary skill in theart will recognize biocompatible materials other than those listedherein that would perform suitably for the bases 16 and 24, the towers30, and/or the retainers 44.

The difference in the material properties including the use of differentmaterials of the retainer 44 and the bases 16 and 24 provides manybenefits appreciable by those of ordinary skill in the art. For example,relatively stiff materials, such as buttresses used in the stapler arts,have been known to cause abrasions between the relatively stiffmaterials and the tissue surrounding their implantation. Advantageously,providing the retainer 44 as a relatively stiffer material and embeddingthe retainer 44 within base 16 and/or base 24 in certain embodimentsdisclosed herein enables the implant 10 to obtain both the stiffeningproperties of the retainer 44 and the low-abrasion and compliableproperties of the bases 16 and/or 24.

In one embodiment, strands of retainer 44 are arranged in a directiongenerally perpendicular to a first orientation of tip(s) 40 (FIG. 11). Awidth of interstices 48 (see FIG. 7A) existing between the strands 46,shown by cross-section in FIG. 8 to be perpendicular with the drawingsheet (i.e., in and out of the page) with the reference numeral w1, issmaller than the horizontal widths of the tip 40 with respect to each ofthe barbs 42 a and 42 b, which widths are designated in FIG. 8 withreference numerals w2 and w3, respectively. In this way, the strands 46that contact each of the tips 40 are moved with respect to and/or pushedapart by the tips 40 (facilitated by the angled or tapered shape of thetips 40) to the widths w2 and/or w3 as the tips 40 are actuated/advancedinto the base 16. By making the bases 16 and/or 24 from a flexible, yetresilient and/or elastically deformable material, such as siliconerubber, after one or more of the barbs 42 of the tips 40 are forciblymoved through the retainer 44, the resiliency of the material of thereceiver base 16 causes at least one of the strands 46 of the retainer44 to revert back to, or towards, the initial width w. The material ofthe retainer 44 can additionally or alternatively provide resiliency toassist in reverting the strands 46 back toward their originalconfiguration. When reverted back towards the original width w1, thestrands 46 are positioned in alignment with one or more of the undercuts27 formed by barbs 42, resulting in the aforementioned engagementbetween the retainer 44 and the fasteners 32, as shown in FIG. 11. Inone embodiment, the strands 46 have a cross-sectional sectional roundshape and associated radius that is less than 1.75 times any radiusformed by the undercuts 27, more preferably less than 1.3 times, andeven less than 1.0 times the radius of the strands. It should also benoted that in embodiments wherein the retainer has strands in different,generally orthogonal directions, the width(s) w4 (see FIGS. 7A and 7B)(which would be orthogonal to the widths w1) would be arranged such thattips 40 would be able to travel beyond any interstice formed between theadjacent strands. While many dimensions of w4 would be possible,non-limiting examples include between 1 times the magnitude of thethickness of barb 42, and six times the magnitude of barb 42. Dependingon the dimension of w1, w4 could of course be smaller than the thicknessof barb 42. The retainer 44 restricts movement of the fasteners 32 in adirection opposite to a direction of deployment of the fasteners 32after the fasteners 32 have advanced through the interstices 48 and areengaged with the retainer 44.

Advantageously, the use of the retainer 44 and the fasteners 32 may helpto avoid the need for accurate alignment between the members 12 and 14,the retainer 44 and the fasteners 32, etc., or for strict manufacturingtolerances for any of the components of the implant 10 in someembodiments. For example, by setting the width w1 between each set ofadjacent strands 46 of the retainer 44 to be smaller than the widths ofthe tips 40 at the barbs 42, the fasteners 32 do not need to beaccurately aligned with the retainer 44 before actuating the fasteners32. That is, the barbs 42 will engage any part of the retainer 44, so itis unimportant where the tips 40 of the fasteners 32 are received by thereceiver member 12 and penetrate into the base 16. For example, even ifthe members 12 and 14, are slightly misaligned during manufacture, andmay become slightly misaligned during firing, the legs 36 of thefastener 32 become slightly tilted or bent (e.g., due to actuationthrough tissue or through the bases 16 and/or 24), or if there aremanufacturing variances or loose tolerances in the size of thecomponents of the implant 10 or positioning of the retainer within thebase 16 (e.g., the interstices 48 are not exactly centered on the tips40), etc., the barbs 42 will regardless catch on some portion of theretainer 44 and maintain the position shown for example in FIG. 11, andthe implant 10 will function properly.

The implant 10 is designed to be installable on a range of differentsurgical structures including those varying in size and/or type. Asnoted above, the towers 30 are compressed by the fasteners 32 when thefasteners 32 are actuated toward the receiver member 12. Advantageously,the range that the towers 30 can be compressed (i.e., the strainapplied) enables the implant 10 to accommodate a corresponding variablerange of surgical structure thicknesses between the structure contactingsurfaces 18 and 26. For example, as illustrated in FIG. 3, the tower 30,in its uncompressed state, initially has a height h1. It is noted thatthe height of the towers 30 may be reduced from a maximum unstressedheight after the fasteners 32 are added, e.g., due to the fasteners 32engaging with a retainer disposed within the base 24, but that referenceto the height h1 as the initial height is suitable in any event forpurposes of comparison herein.

FIGS. 9-11 show an example of one of the subassemblies 34 sealing a thinsurgical structure 50, at which the towers 30 have a partiallycompressed height h2, and FIGS. 12-14 show an example of one of thesubassemblies 34 sealing a thick surgical structure 52, at which thetowers 30 have a minimum or fully compressed height h3. As the thicknessof the surgical structure increases, the towers 30 are furthercompressed from their initial height h1 toward the minimum height h3 inorder to enable the legs 36 of the fasteners 32 to span the increaseddifference and engage with the retainer 44. It should also be recognizedthat surgical structures of varying thickness can be fastened and/orsealed with the same implant, such that some towers of the implantcompress to the height h2 while others compress to height h3, or toother heights between the heights h1 and h3, while in their retainedstate. Advantageously, even if different towers 30 of the same implant10 are compressed to different heights, e.g., due to the surgicalstructure having different thicknesses, the surgical structurecontacting surfaces 18 and 26 will not become distorted, wrinkled,buckled, bent, etc., and therefore be able to contact flush against thesurgical structure along the entire length of the implant 10. Stateddifferently, the independent compressibility of each of the towers 30allows for adjacent towers 30 to compress to different degreesindependently of and without imparting potentially undesirable stressesto adjacent towers 30 when the implant 10 is installed on surgicalstructures of varying thicknesses.

The offset between the barbs 42 a and 42 b along the length of the legs36 can also facilitate the accommodation of each size of the fasteners32 to be usable for a range of surgical structure thicknesses. Thisfunctionality can be appreciated by comparing FIGS. 11 and 14.Specifically, in FIG. 11, the structure 50 is relatively thin, so thetips 40 are able to easily extend deeply through the receiver member 12,such that both of the barbs 42 a and 42 b pass fully through theretainer 44, and the barbs 42 b engage therewith when the driving forceis released. In the embodiment of FIG. 14, the increased thickness ofthe structure 52 may be such that only the barbs 42 a, further along thelength of the legs 36, are able to penetrate fully through and beretained by the retainer 44. It is to be appreciated that any number ofbarbs may be included along the length of the leg(s) of the fastenersand that each fastener may have any number of legs. For example, afastener 56 is shown in FIG. 15 having five barbs 58 a-e along itslength, and only a single leg 60 extending from a body 62.

It is additionally noted with respect to FIG. 11 that the barbs 42 canbe arranged to face opposite from each other, as with the barbs 42 a inthis Figure, such that the retainer 44 is grabbed by the fasteners 32 atdifferent locations, e.g., at different ones of the strands 46 a, asillustrated. This may be helpful in some embodiments to spread out theloading on the retainer 44, e.g., and prevent localized overloading of asingle strand or of the implant 10. That is, the barbs are positioned ininterstices along different lines of the interstices. If desired, e.g.,in order to further spread out the loading, the fasteners 32 mayadditionally or alternatively be rotated, offset, or misaligned withrespect to the members 12 and 14, the retainer 44, the strands 46, etc.That is, as shown by example in FIG. 16A, the legs 36 of the fastener 32may be rotationally orientated about an axis 63 of the towers 30 by anangle θ, such that a line 64 bisecting the legs 36 is rotationallyoffset by the angle θ with respect to a datum line 65 (which may beoriented to be parallel with the member 14 and/or bisect the member 14).In one embodiment, the angle θ is between about 5° and about 45°, and ina further embodiment, the angle θ is about 20°, although those ofordinary skill in the art can select other angles outside of thesevalues, including arranging the axes 64 and 65 to be parallel orperpendicular to each other. It is also contemplated that different legs36 of different fasteners 32 may be oriented to different degrees.

It is noted that the towers 30 are shown schematically in theircompressed states throughout many of the Figures for clarity ofillustration, but that in actual use some degree of buckling, twisting,bending, or bulging of the towers 30 may occur during compression by thefasteners 32. One such example of the compression of one of the towers30 is illustrated in FIG. 17, in which the illustrated tower 30 isbuckling, bending, and bulging due to compression caused by the fastener32. It can be appreciated that in addition to connecting the two legs 36together, the body 38 may also be shaped to assist in maintainingengagement between the fasteners 32 and the towers 30. For example, thefasteners 32 in the illustrated embodiment include a pair of wings 54(e.g., FIGS. 6 and 9) to increase the contact area between the fasteners32 and the towers 30 and thereby maintain contact with the towers 30even as they change shape during bucking, bulging, bending, or otherdistortion. It is also noted that one or more supports 39 may optionallybe included with the towers 30 in order to assist in setting therigidity, bending stiffness, or other properties of the tower 30 (e.g.,thereby influencing the force exerted by the towers 30 duringcompression), and/or to assist in directing the aforementioned buckling,bending, etc., to occur in a more consistent and/or predictable manner.For example, in the illustrated embodiment, the supports 39 are locatedapproximately equally spaced between the legs 36 of the fastener 32 inorder to promote the buckling to occur under the body 38 and to assistin preventing the tower 30 from becoming disengaged from the fastener 32during compression.

The implant 10 is illustrated in a variety of disclosed embodiments tobe essentially longitudinally straight and elongate, having a first endand a second end (e.g., see FIGS. 1-2, 27, 28, 31-33). In theseembodiments, the individual fasteners are arranged along alongitudinally extending row substantially parallel to a longitudinalaxis of the fastener supporting member, and the fastener supportingmember has a length exceeding its width (and the width of the fastenerreceiving member which also has a length exceeding its width). Ifmultiple rows are provided, the rows are preferably substantiallyparallel. It is to be understood that other implant shapes can be used.For example, FIG. 18 shows a top view of an implant 66 according to analternate embodiment. As can be seen in this Figure, the implant 66 iscircular, disc, or ring shaped, with a plurality of the segments 28disposed thereabout (a plurality of the segments 20 in a receivingmember would be arranged opposite thereto, but are hidden from view inFIG. 18). Such an implant may be useful, for example, in so-calledend-to-end, side-to-side, and/or end-to-side operations, such as gastricbypass in which an end section of a patient's intestine is secured tothe patient's stomach about an opening formed in the wall of thestomach. A circular cutting knife (including for instance a knife thatcan follow a circular path consistent with the circular implant 66) canbe utilized with the device applying circular implant 66.

An implant 68 is illustrated in FIG. 19 according to another embodimentThe implant 68 is shaped along an arc or curve, and also includes aplurality of the segments 28 (corresponding to a plurality of thesegments 20 of a receiver member, hidden from view in FIG. 19). Such animplant may be useful for complex tissue structures, or bulk tissuestructures having curvature thereto, such as lungs or other organs. Theimplant is shown in an approximately 180° arc, however, implants oflarger and smaller arcs may be desirable depending on the particularsurgical procedure. An arcuate cutting knife or blade (or at least ablade intended to follow the general path of the arc-shaped implant) canbe utilized. Additionally, in any of the disclosed embodiments, theoutermost lateral regions of the bases of the implants may be cut or“scalloped” (see for example dotted border 67 shown in FIGS. 18 and 19)in a manner that provides for enhanced bending in a direction thatfacilitates allowing additional curvature to arrange the implant 66 or68 to a final shape different than its original shape.

It is also to be understood that the retainer 44 can take a plurality ofother forms embedded or supported within the base of a receiver member.For example, FIGS. 20-26 depict various receiver bases having differentretainers therein, which can be used additionally with, or alternativelyto, the retainer 44. As with the base 16 and the retainer 44, each ofthe bases and retainers in FIGS. 20-26 can be arranged with the basemade of a relatively soft, flexible, or penetrable material, while theretainer is made from a relatively stronger or stiffer material, or amaterial otherwise having different material properties, including butnot limited to different moduli of elasticity, Shore hardness values,yield strengths, etc.

An exemplary receiver base 70 in FIG. 20 includes a retainer 72, whichtakes the form of a plurality of strands 74. The strands 74 resemble thelongitudinal strands 46 a of FIG. 7A, but without the transverse strands46 b, and are also preferably arranged to be coplanar with each other,and/or parallel to the dorsum of the base 70. An exemplary receiver base76 in FIG. 21 has a retainer 78 that substantially resembles theretainer 72, being formed from a plurality of longitudinal strands 80.Unlike the retainer 72, the strands 80 of the retainer 78 are located ata plurality of different heights within the base 76, and therefore notall are coplanar with each other. A receiver base 82 in FIG. 22 includesretainer 84 formed from a plurality of longitudinal strands 85 havingtransverse pins, arms, or fingers 86 extending therefrom. Suchtransverse members may be formed unitarily with the strands 85, oralternatively may be non-unitary and attached or connected. A receiverbase 86 in FIG. 23 includes a retainer 88 formed by one (shown) or more(not shown) undulating or sinusoidal strands 90. A receiver base 92 inFIG. 24 includes a retainer 94 formed by one or more coiled, helical, orspiraling strands 96. A receiver base 98 in FIG. 25 includes a retainer100 formed by a plurality of fuzzy, tangled, intertwined, yarn-like, orbraided strands 102. A receiver base 104 in FIG. 26 includes a retainer106 formed by a plate or membrane 108 having a plurality of taperedelements 110. The tapered elements 110 form an entry opening 112 that issignificantly larger than an exit passage 114 due to shoulders 116. Inthis way, the tips 40 of the fasteners can pass by the entry passage112, pierce through the membrane 108, and push the elements 110 aside topass through the exit passage 114 while moved in the actuationdirection, and then be caught on the shoulders 116. The retainers ofFIGS. 20-26 can extend the full length or partial length of the receiverbase, and can extend the full width or partial width of the receiverbase. The retainers of the embodiments disclosed herein can in certainembodiments be fully embedded in the receiver member such that it is outof contact with tissue or other surgical structure engaged by theimplant.

FIGS. 27A and 27B illustrate the implant 10 of FIGS. 1 and 2 installedon a vessel 118 type of surgical structure, e.g., a conduit such as avein or artery. The vessel 118 includes a lumen 120 extendingtherethough, i.e., preferably for carrying blood. Installing the implant10 on the vessel 118 (that is, compressing the vessel 118 between themembers 12 and 14, and securing (coupling) the members 12 and 14together with the fasteners 32, closes or pinches off the lumen 120,which may be useful, for example, in preventing or impeding blood flowthrough the lumen 120 of the vessel 118. It may be desired, for example,to seal off a blood vessel during a vessel harvesting operation, e.g.,in preparation of using the harvested vessel in a graft surgery such asCABG. For example, in order to harvest a vessel, a first one of theimplants 10 can be installed in a first location of a target vessel, asecond one of the implants 10 installed at a second location of thevessel, with the vessel portion between the two implants 10 removed fromthe patient.

FIGS. 27C-27F illustrate an alternate embodiment of an implant installedon a vessel type of surgical structure. The implant 750 is identical tothe implant 10 except for the provision of flaps or flanges 752.Therefore, only the flaps 752 will be discussed in detail, it beingunderstood that the implant 750 includes a receiver member, deploymentmember, compressible members, e.g., towers, fasteners, retainers, etc.,in the same way as described in detail with regard to implant 10.Consequently, the discussion of implant 10 (and its variations ofstructure and components) is fully applicable to the implant 750 ofFIGS. 27C-27F. Implant 750 has a pair of flexible flaps 752 a on thereceiver member 754 and a pair of flexible flaps 752 b on the deploymentmember 756. The flaps 752 a, 752 b are referred to collectively as theflaps 752. The flaps 752 create a softer sealing pressure gradient oftissue. The flaps 752 extend from the edge of both the receiver member754 and the deployment member 756, extending radially (laterally) onopposing sides of these members 754, 756. In the preferred embodiments,the flaps 752 have a sufficient width to perform their pressuredistribution function but are of small enough width so they do notrequire an increase in the overall width of the jaws of the applicatorwhich support the receiver member 754 and the deployment member 756.

In the illustrated embodiment, the flaps 752 are a continuation of theimplant material itself, such as a continuation of the silicon andretainer, e.g., mesh, and are formed with sufficient stiffness todistribute the sealing pressure over a greater distance than would bedistributed in the absence of the flaps. In some embodiments, the flaps752 can distribute the sealing pressure on vessel 118 over a distance ofapproximately 3 mm, although other sizes, configurations and structureof the flaps are also contemplated to distribute pressure over differentdistances. The end view of FIG. 27D shows the flexure of the flaps 752when applied to tissue or to surgical structure; the end views of FIGS.27E and 27F do not show such flexure. The vessel 118 is shown by way ofexample as the implant 750 can be applied to other structures as well.Additionally, other implants described herein could be provided with theflaps to distribute the pressure.

As can be appreciated, with the provision of the flaps 752, which extendradially from the implant 750, and illustratively extend along thelength of the implant 750, instead of going from sealing pressure to nopressure in a short distance which can increase the risk of tearingtissue, the flaps 752 spread the pressure gradient from sealing to nopressure over a greater distance to thereby reduce stress on tissue. Inorder to seal tissue, the tissue (or other surgical structure beingclamped between the deployment and receiver members) needs to be broughtinto approximation, and this transition from bulk tissue to sealedtissue creates significant stresses on the tissue. The amount of stressis dependent on how quickly the sealing pressure is developed. Thesharper the change in pressure, the greater the stress of the tissue,and the greater the stress on the tissue, the greater the chance thatthe tissue can tear and create a leak. An example of such occurrence isin lung parenchyma which in certain applications can transition frombulk tissue of about 30 mm thickness to sealed tissue at less than 4 mmthickness. Lung parenchyma is also fragile, and if such change occursover too short a distance, the tissue may be overstressed and can tear,which can adversely affect the sealing function. Such abrupt transitionis not fully accounted for in current staples.

The stiffness of the flaps 752 can be varied to provide increasedstiffness for use, for example, in stiffer tissue. The length of theflaps can also be varied, e.g., extending the entire length of theimplant or over less than the entire length. Moreover, the flaps 752 asdescribed above are a continuation of the implant composed for exampleof silicon, e.g., the same material as the deployment member 756 (whichcan be the same materials used for deployment member 14) and thereceiver member 754 (which can be the same materials as used for thereceiver member 12), with a portion of the retainer, e.g., mesh,contained (e.g., embedded) therein. Alternatively, the flaps could notinclude the retainer therein and/or the flaps could be made of adifferent material than the deployment member 756 and/or the receivermember 754. The flaps 752 also could be separate components and notintegral with the implant material, i.e., not integral with thedeployment member 756 and/or the receiver member 754. Alternatively, theflap could be provided on only one of the receiver member 754 ordeployment (fastener supporting) member 756 and not on both the receivermember and deployment member as described above.

As also shown in the embodiment of FIG. 27F, a gap or space 758 can beprovided in the implant 750 adjacent the compressible members. Thisprovides space for the compressible members, e.g., towers 30, of theimplant to laterally expand when compressed by the fasteners 32, orother fasteners disclosed herein. Such gap 758 facilitates release ofthe fasteners 32 from the jaw of the applicator which applies theimplant. (The applicator for applying the implant is described below).That is, when the towers 30 are compressed by the fasteners 32 in themanner described above, since they have room to expand laterally, thepossibility of the towers 30 binding to the jaw and not releasing easilyfrom the jaw is reduced.

FIG. 27G illustrates an alternate embodiment of the compressible membersof the present disclosure which reduce the extent of lateral expansionwhich can be beneficial in certain applications. As shown, thecompressible members of the implant which are engaged and compressed(deformed) by the fasteners 32 in the manner described above as thefasteners 32 are advanced from the deployment member 14 toward and intothe receiver member 12, are in the form of tower like structures as intowers 30 of FIG. 5. However, in this alternate embodiment, the towers,designated by reference numeral 760, have an opening 762 at its dorsalend and an elongated channel 764 extending therethrough, or at leastpartially therethrough. The channel 764 provides a hollowed out area togive the tower 760 volume to expand into when compressed by itsrespective fastener 32, or other fasteners described herein. The channel764 is shown centered within the tower 760, aligned with thelongitudinal axis of the tower 760. By enabling expansion in an interiortoward the longitudinal axis of the tower 760, the extent of radial(lateral) expansion in directions away from the longitudinal axis isreduced which can reduce the likelihood of the towers 760 binding to theapplicator jaw and make release of the implant from the applicator jaweasier. Release with minimal force reduces the risk of injuring sealedtissue or dislodging the fasteners or implant. For clarity, not all ofthe towers are labeled in FIG. 27G. Note also that FIG. 27G shows two ofthe towers sectioned (one in each of the longitudinally extending rows)to better illustrate the channel 764. Note the towers 760 with channels764 can be utilized with the feature of gap 758 of FIG. 27F or usedwithout such feature. The compressible members 760 with channels 764 canbe used with other implants described herein and can be arranged alignedwith the longitudinal axis of the fastener supporting member or at anangle to the longitudinal axis in accordance with the variousembodiments described herein.

Referring back to implant 10, in order to facilitate removal of aportion of the tissue structure in which the implants disclosed hereinare installed, e.g., for harvesting a portion of the vessel 118,removing cancerous tissue or tumors, performing a gastric bypass, etc.,the implant 10 in the illustrated embodiment includes the two rows 35 aand 35 b. A channel 124 is formed between the two rows 35. By firstactuating the fasteners 32 in both of the rows 35 and then cutting thetissue along the channel 124 between the rows 35, the tissue structureon both sides of the cut will be sealed by the implant 10. The bridge(s)37 (see FIG. 1) connecting between the rows 35 may be severed duringcutting. While the bridges 37 are shown in various embodiments to be onone end of elongate implants, in embodiments contemplated herein, theymay be on both ends.

A seal 125 in the tissue or vessel 118 formed by the implant 10 can beseen in FIGS. 30A and 31. The seal 125 represents the portion of thevessel 118 that is compressed or clamped by the implant 10 and can behelpful, for example, in preventing, blocking, hindering, or otherwiseimpeding the flow of blood through the vessel 118. The above-discussedindependent compressibility of the towers 30 and the operation of thetowers 30 compressing to various degrees in response to differentsurgical structure thicknesses are also easily appreciable in view ofthe cross-sections of FIGS. 29-31. For example, it can be clearly seenthat the height of the towers 30 in FIG. 30A, which Figure is taken incross-section at a location with no tissue, is substantially less thanthe height of the towers 30 in FIG. 29, which Figure is taken incross-section through the implant 10 installed on the vessel 118. FIG.30B is a cross-section taken through the region between the towers 30and not in contact with the tissue or vessel, as shown by section line30B-30B of FIG. 27A FIG. 31 is a longitudinal cross-section extendingdown the longitudinal length of a row of the implant 10, which alsoshows the difference in the compressed tower height in response totissue thickness.

An implant 128 according to another exemplary embodiment is shown inFIG. 33. The implant 128 resembles the implant 10, but includes only asingle row 130 of the fastener subassemblies 34. The implant 128 may beuseful in situations in which a cut is not required, or in which sealingon only one side of the cut is desired. If sealing is desired on bothsides of a cut, then two of the implants 128 can be installed adjacentto each other on the vessel 118 or other surgical structure in order tocreate a suitable cutting channel, as illustrated in FIG. 32.

It is again to be appreciated that blood vessels are only one type oftissue structure that can be fastened and/or sealed and blood flow isonly one example of a fluid flow that can be impeded by use of theimplant 10. In one embodiment, the implant 10 is installed in organparenchyma in order to facilitate the removal of a portion of the organ,e.g., a tumor or cancerous growth. In another embodiment, the implant 10is used to complete a gastrointestinal bypass. In one embodiment, one ormore of the implants 10 are installed in a patient's lung parenchyma inorder to prevent the leaking of air while removing a portion of thepatient's lung. It is appreciated by those of ordinary skill in the artthat the implants 10 can be used for not only hemostasis andpneumostasis, but to seal off the flow of other desired fluids fromvarious tissue structures. One example embodiment for connecting a firstsurgical structure 132 to a second surgical structure 133 is shown inFIGS. 34 and 35. In one embodiment, the first and second surgicalstructures represent intestinal structures, and the implant 10 is usefulfor performing an intestinal anastomoses. In such a procedure, one ormore of the implants 10 are installed with the corresponding receivermembers 12 in the first structure 132 and the deployment members 14 inthe second structure 133, which are connected together with thefasteners 32 and retainer 44 as disclosed above. This connects the firstand second structures 132 and 133 along a length thereof to create aso-called side-to-side connection 134. It is again noted that this isprovided as just one example of a procedure that can be performed withassistance of embodiments of the present invention described herein andis accordingly not intended to be limiting.

Implant Method of Manufacture and Fabrication

Implants consistent with the present disclosure may be constructed in avariety of ways. In certain embodiments for example, fabrication of theimplant may involve (i) molding at least two implant halves (e.g., thereceiver member 12 and/or the deployment member 14) or bases (e.g., thebase 16 and/or the base 24 of the deployment member 14) with one or moremolding steps, (ii) assembling one or more fasteners (e.g., thefasteners 32) to (or alternatively molding with) the one or more basesand/or implant halves. (iii) placing the one or more bases and/orimplant halves in alignment with an end effector (e.g., jaws of anapplicator, device, instrument, or mechanism for installing implants,such as those discussed below in more detail) and/or the other of theone or more bases and/or implant halves, and (iv) sterilizing the one ormore bases and/or implant halves. The molding step may involveco-molding or over-molding with the base one or more strands, webstructure, knit structure, woven structure, mesh, and/or any otherstructure suitable for a retainer (e.g., the retainer 44) or to impartstiffening properties to the base. The mold cavity(ies) are configuredbased on both the desired shapes of the bases (e.g., the bases 16 and/or24) and/or implant halves (e.g., the receiver member 12 and/or thedeployment member 14) as well as the shrinkage characteristics of themolded material to produce one or more bases and/or implant halves. Thebases and/or implant halves may for instance have the same, similar, oreven different structures, as exemplified by the drawings of the presentdisclosure. The mold cavities forming the ventrum surface(s) of thebases and/or implant halves may have one or more protrusions that assistin placing a retainer (e.g., the retainer 44) and/or retaining elementssuch as strands/knit/mesh/weave, etc. (e.g., the strands 46) apredetermined distance away from the ventrum surface (e.g., the surfaces18 and/or 26) of the implant (e.g., the implant 10). This may be formedby example via the use of one or more lengthwise protrusions, and mayresult in one or more corresponding grooves 17, (best shown in FIGS. 5and 6) at the ventrum surface. Instead of the ventrum surface, portionsof the dorsal surface may be used as an alternative means to accomplishthe same.

The bases and/or implant halves are preferably formed of a relativelysoft, flexible, penetrable and/or puncturable, but also resilientmaterial, such as silicone rubber, as discussed above. The siliconerubber or other material may be injection molded or cast. The towers 30formed within the implant may be molded of the same material as thebases, or alternatively may be co-molded or over-molded of a differentmaterial, or optionally of the same material family but having differentspecific properties such as elasticity and/or Shore A hardness.

Additionally, the mold cavities/core pins, etc. used for forming thebases and/or implant halves are sized and shaped such that when theimplant 10 is represented as a beam, each half thereof (e.g., thereceiver member 12 and/or the deployment member 14) will have a neutralaxis 172, 174 (i.e., theoretical location where bending stress is zero)along the length of each half and that is closer to the ventrum (orplane of contact 170 when no tissue or structure is disposed between thehalves) than the dorsum portion of each half (see FIGS. 30A and 30B).The location of the neutral axis will move depending on the relativesecond area moment of inertia and stiffness properties along the implant10. This is illustrated for example in FIGS. 30A and 30B, wherein theneutral axis 172, 174 is schematically represented for each of therespective cross-sections. In one exemplary embodiment, the neutral axis172 of the receiver member 12 is closer to the ventrum than for thecorresponding neutral axis 174 of the deployment member 14. When aretainer 44 having a material property of a higher modulus of elasticitythan the material chosen for the base (or overall receivermember/deployment member) is integrated to the bases of each halves, theneutral axis is moved even more towards the ventrum. This results in aneutral axis for at least one, and preferably both halves, in which theheight 180, 176 of the neutral axis 172, 174 from the ventrum or planeof contact 170 is about 40% or less than the section's overall height178, 182, possibly about 35% or less, more preferably about 30% or less,even more preferably about 25% or less, and in certain embodiments about20% or less. In certain embodiments, the modulus of elasticity for theretainer 44 is 100 times greater than that of the molded portions of thereceiver member and deployment member, more preferably 200 timesgreater, even more preferably 400 times greater, even more preferably600 times greater, even more preferably 800 or even 1000 times greater.Additionally, in some embodiments the shape and material properties maybe chosen such that the resulting half (including retainer 44) wouldhave a bending stiffness (i.e., modulus of elasticity multiplied by thesecond moment of area) of about 1.3×10⁻¹¹ MPa m⁴ or greater, morepreferably 1.8×10⁻¹¹ MPa m⁴ or greater, even more preferably 2.2×10⁻¹¹MPa m⁴ or greater, more preferably 2.7×10⁻¹¹ MPa m⁴ or greater, and evenmore preferably 3.0×10⁻¹¹ MPa m⁴ or greater.

The strands (e.g., the strands 46) of the retainer may be formed aseither unique strands, or optionally as a portion of a knit, mesh, weaveor similar structure, of which the material chosen may be polypropylene,polyester (PET), PEEK, Nylon, or the other materials discussed above,and/or combinations thereof. When multiple connected or formed strandsare used (such as in a mesh), a variety of spacings or openings may bechosen depending on the size of the fastener selected. Openings (e.g.,the interstices 48) may be for example anywhere from 0.500 inches to0.001 inches, more preferably 0.250 inches to 0.005 inches, even morepreferably 0.100 inches to 0.010 inches, and even more preferably 0.050to 0.020 inches, and yet further between 0.025 inches to 0.030 inches.The open areas (e.g., the interstices 48) between crisscrossing strands(e.g., the strands 46) when utilized are preferably sized in accordancewith the size and shape of the fastener (e.g., the fastener 32) chosen.Examples may include, for instance, ranges between 0.001 sq·in. to 0.100sq·in., more preferably 0.0001 sq·in. to 0.0080 sq·in., even morepreferably 0.0002 sq·in. to 0.0020 sq. in., 0.0003 sq·in, to 0.0012sq·in., and most preferably about 0.0005 sq·in. to 0.0010 sq·in. Suchopen spaces (e.g., the interstices 48) may be square, rectangular,diamond-shaped, and/or other types of polygonal shapes may be utilized.Triangular and circular or elliptical shapes are also contemplated, aswell as any of the shapes and structures shown by example in FIGS. 7aand 7b (shown without the base) and FIGS. 20-26 (shown with the base).

In a sample embodiment, a mesh having a crisscrossing constructionforming generally square openings of a precision polyester is chosen(see for example FIG. 7B). Such meshes may be sourced for instancethrough McMaster-Carr (Robbinsville, N.J., USA). The mesh is cut in amanner that facilitates its later placement into a mold cavity.Preferably, the mesh is cut such that the mesh self-aligns to begenerally centered in the mold cavity chosen for the base(s) (e.g., thebases 16 and/or 24). The mesh is then placed in the mold, and thenformed within liquefied silicone under conditions that permit thesilicone to form around the mesh. While many silicones, such as medicalgrade and/or food grade silicones may work, implant grade silicones arepreferred. Preferably, the hardness of the silicone (once cured) is of aShore A durometer between 5 and 55, more preferably 10 and 45, morepreferably 20 and 40, and most preferably about between 25 and 35, suchas 30. Of course, materials with a Shore A durometer above 55 or below 5may also be used depending on the situation. Materials may be sourcedfrom a variety of vendors, including for instance Applied SiliconeCorporation (Santa Paula, Calif., USA), and Dow Corning Corporation(Corning, N.Y., USA) under the trade name SILASTIC.

After the mold cavity has been set and filled, the liquefied silicone iscured and removed for subsequent assembly with a fastener. Before,during, or after the process of forming the halves, one or morefasteners (e.g., the fasteners 32) are fabricated for being joined orintegrated with at least one of the halves. In an example embodiment,the fasteners 32 are first formed in a strip 140 of metal (e.g., 304 or301 stainless steel) through a chemical etching process, although othermachining processes such as wire EDM and stamping/punching and/or diecutting may be used. The resulting strip 140 is illustrated in FIGS. 43Aand 43B, and has one or more outside edges 142 connected to the fastenerbodies 38 of each flat-formed fastener body 33 at one or more locations144 per fastener body 38. The flat-formed fastener bodies 38 are shownin FIGS. 43 and 44 to be radially oriented in an overlapping pattern,offset a width or distance 152 as shown in FIG. 43B. The offsetdistance(s) 152 preferably is chosen so that each fastener 32 alignswith its respective tower 30 of the half it will be integrated with.

The strip 140 is then placed in a forming tool (not shown) which alignsthe strip 140 with one or more anvils (not shown) to facilitate bendingof the one or more of the legs 36 to an orientation generallynormal/perpendicular to the plane of the strip 140. Alignment with theforming tool may be achieved with the assistance of alignment apertures31. Sufficient pressure is then applied against the legs 36 to transformthe flat-formed fastener body 33 shown in FIGS. 36 and 37 into theshaped fastener 32 of FIGS. 38-42. While the primary leg 36 of thefastener may have a single width throughout, in other embodiments it mayhave a wide section defined by the width 146 as well as a narrowersection defined by a width 148, as shown in FIG. 36. A bend 154 causedby the deforming step may occur within any portion of the leg 36 butpreferably occurs within the wide section 146 for those legs 36 havingvarying widths, and forms a curve about an axis 156 that provides asmooth transition between the leg 36 and the body 38. Additionally, aspacing 153 of the legs (FIG. 40) is chosen such that there is little,minor, or no interference between the fastener 32 legs 16 and the towers30 once assembled together. That is, preferably the spacing 153 exceedsthe width of the tower 30 over which the fastener is mounted.

The tips 40 of the shaped fastener(s) 32 may optionally then besharpened on one or more of their edges to achieve a sufficientreduction in penetrating forces depending on the material(s) of thebases 16 and/or 24, as well as the tissue or structure intended to bepierced. As shown in the embodiment of FIGS. 41 and 42, edges 41B arebeveled or sharpened, and may in some embodiments only be beveled on theoutermost surface of the legs 36. The beveling may occur when thefastener is flat-formed as shown in FIGS. 36 and 37, or alternately whenit is formed in a bent configuration as shown for example in FIGS.38-42. Other tip designs could alternately be provided.

One or both of the towers 30 and fasteners 32 may be lubricated tofacilitate reciprocal movement of each structure with respect to theother. In some instances, the fastener 32 may be dip coated into PTFE toreduce the friction should contact occur between the fastener 32 andtower 30. Other lubricants may also be suitable.

Each fastener 32 may subsequently be aligned with a corresponding one ofthe towers 30. This may be achieved individually or simultaneously witha plurality of the fasteners 32. For instance, when the bent fasteners32 are still interconnected in the strip format 140, the strip 140 canbe used as an alignment tool for facilitating assembly of the fasteners32 simultaneously onto multiple ones of the towers 30 of a deploymentmember 14. The alignment apertures 25 (see FIG. 5) located within thebases 24 on opposite sides of the towers 30 may be provided to furtherfacilitate assembly, by providing a guiding hole for the tips 40 to beplaced in during the alignment step of the fabrication process. Onceproperly aligned, the fasteners 32 may be secured to the base in avariety of manners. In one such exemplary embodiment, frictional forcesmaintain the connection between the fastener and the half. In anotherembodiment, the tips 40 are retained within the base (e.g., the base 24)of the half (e.g., the deployment member 14) associated with the towervia engagement of one or more retaining elements or strands (e.g., thestrands 46) of the retainers (e.g., the retainer 44) positioned in thedeployment member 14.

When assembled via the strip 140, a post-assembly process involving thecutting of the fasteners 32 from the strip outside edges is performed.Instead of a post-assembly process, separation of the fasteners canoccur before attachment to the corresponding base (e.g., the bases 16and/or 24) and/or implant halve(s) (e.g., the deployment member 14).This may allow for in-mold assembly of the fastener with the base and/orhalf as well as in other embodiments co-molding or over-molding of thefastener (e.g., the fastener 32) to the bases and/or halve(s).

FIGS. 44A and 44B illustrate an alternate embodiment of a fastener ofthe implant of the present disclosure The fastener 800 has a base 805and pair of legs 802 extending substantially perpendicular therefrom. Itshould be appreciated that alternatively, the legs 802 can extend at adifferent angle from the base 805. The base 805 has a planar (flat) orsubstantially planar (flat) surface that transitions on opposing sidesinto curved surfaces or bends 807, transitioning into legs 802. The legstaper at region 810 and terminate in penetrating tips 806. Each leg 802has a pair of barbs 808 a, 808 b (collectively barbs 808) at a distalportion. Barbs 808 a, 808 b are preferably identical in configurationand are axially (longitudinally) aligned with respect to the fastenerleg 802. Thus, the barbs 808 a, 808 b are on the same level andsymmetrical around the centerline of the fastener 800 so the fastener800 can pierce the tissue in a straight manner. As discussed herein, insome embodiments, the barbs of the fasteners can be axially(longitudinally) offset with respect to the legs which has certainadvantages. In this embodiment, the barbs are aligned which providesother advantages in certain applications of the fastener.

The aligned barbs of FIGS. 44A and 44B provide a lesser force topenetrate tissue, reduce the chances of twisting as the fastener 800passes through the tissue or other surgical structure and provide formore consistent entanglement with the receiver 44, e.g., mesh, tothereby improve barb to retainer hold strength and reliability. Thealigned barbs also provide for more tissue capacity because the offsetbarbs require a longer fastener or thinner tissue to fit into a givencannula diameter. Thus, by making the barbs 808 a, 808 b the samedistance from the base 804 of fastener 800, the distance the barbs 808a, 808 b need to be driven (as compared to offset barbs) is minimizedand the tissue thickness is maximized. For example, in some embodiments,the tissue thickness capacity is increased about 0.5 mm with the alignedbarbs 808 a, 808 b.

The fastener 800 can also be designed with other features to reduce theforce to drive the fastener 800 through tissue. For example, thefastener can be coated with material such as PTFE and can beelectropolished to remove any burrs or surface roughness. In someembodiments, the penetrating tip can be sharpened to an angle of about35 degrees (see angle B of FIG. 44B). The fastener 800 can be formedfrom a metal sheet using a chemical etching process and in someembodiments formed with this 35 degree angle to achieve both sufficientsharpness to penetrate surgical structure and desired penetration force.It should be appreciated that 35 degrees is provided by way of exampleas other angles can be utilized to obtain desired penetrating force andsufficient sharpness. The tip can be formed by various processes,including by way of example a grinding process after the fastener isformed from a sheet using a chemical etching process.

FIG. 44B illustrates certain dimensions of the fastener 800 to optimizepenetration of surgical structure and engagement with the receiver 44 ofthe receiver member 12 discussed above. It should be appreciated thatthese dimensions are provided by way of example as other dimensions arealso contemplated for the fastener 800. In FIG. 44B, the fastener 800has an increased barb distance w6 (as compared e.g., to the barbs ofFIG. 38) of about 0.013 inches. This improves retention with theretainer, e.g., mesh, to reduce the chances of the fastener 800 slippingout of the retainer 44. The width w7 of the barb securement portion isshown increased (as compared to the barbs of FIG. 38) by about 0.003inches so that it is not degraded when the fastener 800 iselectropolished, i.e., metal is removed from all the surfaces.Additionally, the distance w5 of the barb portion, i.e., the width ofthe fasteners at the outermost regions of the barbs 808 a, 808 b, isabout 0.050 inches. This is wider than the region of the fastener below(proximal/dorsal of) the barbs 808 a, 808 b so the retainer, e.g., mesh,springs back after the barbs 808 a, 808 b pass through the openings inthe retainer 44, and the retainer 44 is thus held securely under thebarbs 808 a, 808 b.

In the alternate embodiment of FIG. 44C-44E, the fastener 820 isidentical to the fastener 800 except for the elongated hook portion 825.Thus, like fastener 800, fastener 820 has a pair of legs 822 extendingfrom a base 824 and terminating in penetrating tips 826. Also, likefastener 800, fastener 820 has a pair of symmetrical longitudinally(axially) aligned barbs 824 a, 824 b. The fastener 820 differs fromfastener 800 in that the hook portion 825 has a longer length and thusthe barbs 824 a, 824 b can also be elongated as compared to barbs 808 a,808 b of FIG. 44A. In a preferred embodiment, the distance D1 of thehook portion, measured from the outermost point of the penetrating tip826 of the fastener 800 to the lowermost (proximalmost/dorsalmost) pointof the barb 824 a is about 0.050 inches. The extended length achievesthe balance of accommodate thicker tissue without extending past thematerial of the deployment member 14 in the pre-fired position as shownin FIGS. 44D and 44E.

The advantage of the extended hook portion can be understood in terms ofan example. As shown in FIG. 44D, the fired fastener 820 is driven about0.16 inches. With a tissue thickness of 0.10 inches (2.5 mm), the barb824 a, 824 b needs to be driven at least 0.12 inches. Thus, it has amargin of error of 0.04 inches (1 mm), to assure successful engagementwith the receiver member 12. This also means that after the jaws areopened, the tissue can expand and additional 1 mm, i.e., to 3.5 mm asthe barb catches onto the retainer 44, e.g., mesh, within the receivermember 12. Thus, the fasteners 820 can cover a large range of tissue.

To fit thicker tissue, the cartridge containing the fasteners 820 can beset back from the issue contacting surface of the deployment member 14.In one example, it is set back about 0.050 inches. When the jaws areclosed to approximate the receiver member 12 and deployment member 14and clamp thick tissue structure between the tissue contacting surfacesof the deployment 14 and receiver member 12, the deployment member 14 ispushed back against the cartridge containing the fasteners 820 up tothis 0.50 mm. This also provides the benefit that as the thick tissue iscompressed, the tips 826 of fasteners 820 can be slightly exposed fromthe cartridge to keep the tissue from being squeezed out of the jaws.

FIGS. 44F and 44G illustrate one process of forming the fasteners 800 ofFIG. 44A. In this embodiment, the fasteners are formed on a strip 812.The strip 812 enables the fasteners 800 to be made in sets in acontinuous process so that a large number of sample parts need not behandled in manufacturing. Also, keeping the fasteners 800 togetherallows them to undergo additional processes after initial cutting (orchemical etching or stamping) in a controllable manner, thereby reducingthe cost of manufacture. As shown in FIG. 44F, the fasteners 800 arealigned and connected along bridge or connector 814. Note, for clarity,only one of the fasteners is labeled in FIGS. 44F and 44G, The leg 802and half of the base 804 extends in one direction from the connector 814and the other leg 802 and other half of the base 804 extends fromconnector 814 in the opposite direction. As shown, ten fasteners areconnected along connector 814, however, it is also contemplated that afewer or greater number of fasteners can be connected along connector814 and provided on a single strip. Also, as shown, the fasteners arepositioned perpendicular to the connector 814 to provide severaladvantages discussed below, however, in alternate embodiments, they arealigned at a different angle to the connector 814. If desired, all ofthe fasteners for the implant can be formed from the single strip 812,although, alternatively, sets of strips 812 each containing a subset ofthe total fasteners for the implant can be formed.

In the next manufacturing step after formation of strip 812, thefasteners 800 are bent to the position of FIG. 44G. The fastener strip812 can be sharpened using a grinding process (after before or after thefasteners 800 are bent to their U-shaped configuration of FIG. 44E). Thefasteners 800 can then be cleaned and coated, such as with a PTFEcoating or other coatings, then cut apart and inserted into thedeployment member, e.g. the silicone/mesh of the deployment member 14discussed above. Although the fasteners 800 on the strip 812 are shownas being identical, in alternate embodiments, different fasteners can beprovided on the strip. Additionally, the fasteners of the otherembodiments disclosed herein can also be formed in strips as in FIG.44D.

Note the positioning of the fasteners 800 perpendicular in the strips812 allows the entire set of fasteners to be bent to the position ofFIG. 44G at one time, sharpened at one pass and cut apart for insertioninto the deployment member 14. It also eliminates the need for pushersas described in more detail below. Further, the bend 807 in thefasteners which places it perpendicular to the driver cam surfaces(discussed below) reduces twisting/rotating of the fasteners 800 duringfiring.

Various materials are described herein for the retainer. In oneembodiment, for use with the fastener 800 or other fasteners describedherein, the retainer in the form of a mesh can be composed of polyester(as noted above) to increase the strength of the mesh. Further, ifdesired to further increase the strength of the mesh, the weave of themesh can be reduced. A tighter weave can increase the resilience of themesh to reform after the barbs 808 a, 808 b pass therethrough, thusbeing caught under the barbs 808 a, 808 b.

In addition to the aforementioned embodiments, additional embodimentsare contemplated. FIG. 45 represents a schematic representation of pairsof fastener/tower structures or deployment segments (e.g., one of thedeployment segments 28 of FIG. 1) (referenced as segments A) alignedwith receiving segments B (e.g., one of the segments 20 of FIG. 1).While FIG. 45 illustrates an arrangement of segments A and B ondifferent halves 160, 162, alternatively the can be arranged on the samehalf 164, as illustrated in FIG. 46. For example, instead of designateddeployment and receiving halves, an implant may be formed fromessentially identical halves 164 having alternating deployment andreceiving segments. That is, in one embodiment, the implant halvesinclude alternating ones of the segments 20 and 28, as representedschematically by the segments A and B in FIG. 46. Furthermore, thehalves do not have to have an equal quantity of segments B to align withthe quantity of segments A, nor are the halves required to directlyoverlap to the corresponding half, as represented in FIG. 47 wherein afirst and second of the segments A of a first half 166 may align withsegments B of different half 168. This may allow for linking multiplehalves together when the length of one half is insufficient for acertain procedure. Many other permutations are of course possible due tothe flexible nature offered by the disclosed embodiments. Additionally,the deployment member can be positioned on the moving jaw and thereceiver member positioned on the stationary jaw as an alternate to theaforedescribed positioning. An example of this configuration isdescribed below with reference to FIG. 79.

It is to be noted that the barbs 42 or other elements suitable forgrabbing, catching, or engaging a retainer may be formed as anystructure that protrudes outwardly and is thus so capable of catching,grabbing, or otherwise engaging with a retainer, such as the retainer 44(which elements are collectively referred to as barbs). For example, inthe embodiment of FIG. 48A, a fastener 185 is formed with a helical orspiraled shank or leg 186. The helical leg 186 is formed with respect toan axis 188. Since the leg 186 has a thickness that is much less thanthe width of the helical shape made by the leg 186 about the axis 188,the leg 186 is able to pass through relatively small openings (e.g., theinterstices 48) while being rotated during forward advancement. In thisway, pulling back against the fastener 185, but without rotation (e.g.,such as would occur due to the force exerted by the towers 30), willcause each turn 189 of the fastener 185 to act as a barb and grab,catch, or engage with a retainer or retaining elements (e.g., thestrands 46 of the retainer 44). Another embodiment is illustrated inFIG. 48B. In this embodiment, a fastener 190 includes a leg 192. Aflange 194 extends from the leg 192. The flange 194 may be a continuousflange, e.g., helically or spirally formed about the leg 192, or formedas discrete elements. Similar to the fastener 186 in FIG. 48A, the leg192 can be advanced through a relatively small opening (e.g., theinterstices 48) by advancing the fastener 190 toward the opening androtating the fastener 190. However, when the fastener 190 is pulled backin the opposite direction without rotation, the flange 194 will act as abarb and catch, grab, or engage with a retainer or retaining elements(e.g., the strands 46 of the retainer 44). Although the fasteners ofFIGS. 48A and 48B are shown with one leg, two or more legs can extendfrom the base (body).

Embodiments of the present disclosure are further directed to anapparatus and method for delivering and implanting one or more surgicalimplants, such as any of the previously described embodiments for orrelated to the surgical implant 10, or other fasteners, clamps, clips orother closure or sealing devices. That is, embodiments of the currentinvention are directed to various alternative and improved devices,apparatus, systems and methods for implanting a surgical implant to, forexample, close a tissue structure of a patient which include but are notlimited to blood vessels, parenchyma, bronchi, atrial appendages and thelike. Tools and implants according to the present invention can beconfigured and dimensioned to seal and transect large vessels and bulktissue up to about 5 mm compressed thickness and may have aconfiguration and size sufficient to fit through a port, such as a port20 mm in diameter or less to allow for minimally invasive surgicalprocedures, and flexible enough to maneuver to an intended surgicaltarget. The surgical implant applicator and system may be designed towell tolerate thickness variations of the tissue to be closed along alength of a surgical implant. The surgical implant applicator of thepresent invention may advantageously also use smaller, less expensiveclosing mechanisms than those used in currently known apparatus, as thesurgical implant to be implanted by the apparatus do not require theamount of precision for alignment and closing that is required ofcurrently known apparatus. Additionally, the surgical implant applicatorcan be provided to mount two surgical implants (or a bisectable singlesurgical implant) and with a cutting element to sever tissue (and theclosure device when a single bisectable device is employed) between twolocations where the tissue has been closed by the closure device(s).Still further alternatively, the surgical implant applicator can beprovided to mount one closure device for implantation in sealing off alocation with the single device.

The applicator described below moves, mounts, and/or applies twoimplants side by side extending generally linearly. It is alsocontemplated that alternatively, the implant can be arrangednon-linearly, including a circular or arcuate arrangement as discussedabove. Although the applicator described is for endoscopic or minimallyinvasive surgical products, it is also contemplated that the implantsdescribed herein can be utilized in “open” procedures. Also, theillustrated applicator is shown to have a rigid shaft, but flexibleshafts and instruments can also be utilized for use in certainendoscopic procedures. Additionally, applicators without a shaft (i.e.,such as a configuration that is “scissor-like” or otherwise resemblesthe gross structure of a long-nose pliers, with two pivoting grips, eachgrip operably engaged with either a top or bottom half of the implant tomove the halves to and from each other), may be utilized.

Referring now to FIG. 50, an isometric view of one embodiment of asystem 1000 for installing surgical implants according to embodimentsdisclosed herein, e.g., the implant 10, is illustrated. As discussedabove, surgical implants disclosed herein, such as the implant 10, canbe useful for closing, sealing, or securing together one or moresurgical structures during a medical procedure performed on a patient.As shown, the system 1000 includes the surgical implant 10 and asurgical implant applicator 500, which may also be referred to as atool, device, instrument, or the like. It is to be appreciated that theimplant 10 may be installed using devices other than the applicator 500,and likewise, that the applicator 500 may be used to install surgicalimplants other than the implant 10. Furthermore, it is noted thataspects of the applicator 500 may be useful in medical procedures thatdo not include surgical implants, e.g., such as any requiring actuatablejaws, slidable actuation of mechanisms along an end effector,articulation or rotation of an end effector, etc., as will be betterappreciated below with respect to the various components and assembliesof the applicator 500.

In FIG. 50, the implant 10 is illustrated as mounted on an end effector502 configured as a distal portion of the surgical implant applicator500. Again, it is to be appreciated that the applicator 500 may be usedfor implanting surgical implants other than the implant 10, e.g.,including the various embodiments discussed herein, and that the implant10 is given as a representative example only. Accordingly, it is notedthat any reference to the implant 10 with respect to the applicator 500is for the purpose of assisting in describing various modes of operatingthe applicator 500.

The end effector assembly 502 of the applicator 500 includes a set ofjaws designated with a jaw 504 a and a jaw 504 b (collectively, “thejaws 504”). Due to the illustrated orientation of the jaws 504throughout the Figures, the jaw 504 a may be referred to herein as theupper jaw, and the jaw 504 b as the lower jaw, although it is to beappreciated that this is for the sake of discussion only and that thejaw 504 a does not necessary have to be “above” the jaw 504 b in otherembodiments (or after changing the orientation of the applicatormanipulating the jaws 504, e.g., as discussed below). FIGS. 50 and51A-51D show the surgical implant applicator 500 in an openconfiguration for the jaws 504, with opposing first and second portionsof the surgical implant 10, namely the receiver member 12 and thedeployment member 14 (e.g., or in other embodiments, others such as thehalves 160, 162, 164, 166, and/or 168 of the implants described withrespect to FIGS. 45-47), mounted in the upper and lower jaws 504 a and504 b, respectively. The surgical implant applicator 500 includes aproximal assembly 506 that is connected to the end effector assembly 502via an elongated shaft (elongated portion) 508 extending therebetween.In one embodiment, the shaft 508 has a diameter of about less than 10mm, and preferably about 8 mm, although other dimensions arecontemplated. The proximal assembly 506 includes a housing 510 having ahandle portion including a handle 512 configured to enable a user tohold and operate the surgical implant applicator 500, e.g., with asingle hand, and a movable handle or handle member in the form of atrigger 514, which may also or alternatively be referred to as a lever,movable actuator, etc. In one embodiment, the trigger 514 is arranged tobe operated by the same hand holding the applicator 500 by the handle512 to effect operation of the end effector 502, e.g., closing, cutting,and/or reset operations that are discussed in more detail below.

The end effector 502 is connected to the shaft 508 and thus the proximalassembly 506 via a joint 516 positioned proximate to a distal end of theshaft 508. A positioning assembly 518 is configured to performarticulation of the end effector 502 (that is, e.g., left and right orside-to-side angulation of the end effector 502 relative to alongitudinal axis 520 of the shaft 508). For example, FIGS. 52A-52D showthe end effector 502 having been angled to the left with respect to theaxis 520 and the orientation of that Figure. Additionally, thepositioning assembly 518 is configured to control rotation of the endeffector 502 about the longitudinal axis 520 of the shaft 516, relativeto the proximal assembly 506. While the end effector 502 is shown to benon-removably attached to the shaft 508, alternatively, it can beremovable with respect to the shaft 508 and replaced by a new endeffector (having a new set of jaws) containing a new implant. Thisenables application of multiple implants in a single procedure. Also,while the shaft may preferably be rigid and straight, in alternativeembodiments it may be flexible and non-rigid.

In one embodiment, the positioning assembly 518 may include a rotationactuator 522 that is mounted to proximal assembly 506, but rotatablewith respect thereto. The rotation actuator 522 may include a pluralityof ribs or ridges 524 that facilitate gripping thereof by a user. Therotation actuator 522 may be non-rotatably mounted with respect to theshaft 508, with the shaft 508 also rotatably mounted to the housing 510,and the end effector 502 non-rotatably mounted to the shaft 508. In thisway, rotation of the actuator 522, e.g., via a user gripping theactuator 522 at the ribs 524 and turning the actuation 522 with respectto the housing 510, causes rotation of the shaft 508 and the attachedend effector 502 about the axis 520. In one embodiment, the rotationactuator 522 enables more than about 90° and preferably about 180″ ofrotation about the axis 520 in either direction.

As noted above, the end effector 502 (also referenced to as the endeffector assembly 502) is pivotally mounted relative to the shaft 508via the joint 516. For example, the joint 516 may be configured toenable rotation or articulation of the end effector 502 about an axis526 (FIG. 51B), which is transverse, e.g., perpendicular, to the axis520. A mechanism can be provided so the end effector 502 is rotatableabout its axis relative to the shaft 520 which remains stationary. Thejaws 504 may be arranged together with the end effector assembly 502 sothat the jaws 504 of the end effector 502 can be articulated, e.g.,pivoted left or right or side-to-side about the axis 526, in unisonrelative to the shaft 508. As shown, there is one stationary jaw and onemovable jaw (i.e., movable with respect to the stationary jaw) totransition the jaws between an open and closed configuration (position),but alternatively both jaws can be movable to transition the jawsbetween an open and closed configuration. Thus, movement of at least onejaw to transition the jaws between open and closed configurationsincludes movement of only one jaw or movement of both jaws. In oneembodiment, the end effector 502 can be articulated by at least about30° to 45° from the axis 520, and preferably about 60° from the axis 520to either side with respect to the axis 520. As noted above, inalternative embodiments the shaft can be flexible instead of rigid asshown. The positioning assembly 518 may include an articulation actuator528 (FIG. 51C) that is configured to cause the above-describedarticulation of the end effector 502 when the articulation actuator 528is rotated. A knob 530 may be included and non-rotatably mounted to theactuator 528 in order to enable a user to rotate the articulationactuator 528 via rotation of the knob 530. Rotation of the articulationactuator 528 in a first direction (such as counterclockwise in theembodiment of FIGS. 52A-52C) may be arranged to cause the end effectorassembly 502, along with the jaws 504, to correspondingly angle in thefirst direction (e.g., to the left relative to the axis 520 by an amountrepresented by an angle α in the embodiment of FIGS. 52A-52C). Rotationof the articulation actuator 528 in a second direction opposite to thefirst direction (such as clockwise in the embodiment of FIGS. 52A-52C)causes end effector 502 and/or the jaws 504 to correspondingly angle inthe second direction (e.g., to the right relative to the axis 520 in theembodiment of FIG. 52A-52C). The further the articulation actuator 528is rotated, the greater the angle of deviation of the end effector 502and the jaws 504 from the longitudinal axis 520 of the shaft 508. Thearticulation movement of the end effector 502 and/or the jaws 504 may bein or with respect to a plane, but it is noted that the plane ofmovement can vary, e.g., be rotated with respect to the axis 520, byrotation of rotation actuator 522.

The articulation actuator 528 may include one or more relief features532, such as scallops, detents, or indents, to provide a predeterminedamount of frictional resistance to the articulation actuator 528 thatallows it to be rotated by hand by a user, but provides sufficientfriction to prevent it from counter-rotating after the user's hand isremoved from the articulation actuator 528. The relief features 532 mayalso provide sufficient friction so that the end effector 502 maintainsthe desired degree of angulation until the user decides to again operatethe articulation actuator 528, e.g., via the knob 530. In the embodimentshown in FIG. 52D, one or more detent balls 534 are resiliently orspring-loadedly mounted to the rotation actuator 526, or other componentof the positioning assembly 518, and interact with the relief features532 to provide the predetermined amount of friction. One or morearticulation drivers may be included, e.g., two such drivers designatedwith the numerals 536 a and 536 b (collectively, “the articulationdrivers 536”), which are shown in FIG. 52C mounted at their proximalends (e.g., pivotally mounted) to the articulation actuator 528. Morespecifically, the articulation drivers 536 may be mounted on oppositesides of the articulation actuator 528 (i.e., the drivers 536 areeccentrically mounted to the actuator 528), such that rotation of thearticulation actuator 528 pushes one of the articulation drivers 536 andpulls the other articulation driver. The distal ends of the articulationdrivers 536 are pivotally mounted to opposite sides of the joint 516,designated with the numerals 538 a and 538 b (FIG. 54C), respectively,to translate the pushing and/or pulling actions to the end effector 502thereby effecting angular articulation of the end effector 502. Thearticulation drivers 536 may preferably be flat ribbons having suitabletensile and/or compressive strength in their axial direction during thepulling and/or pushing operations. Alternatively, the articulationdrivers 536 may be rigid rods or the like. In one embodiment,articulation drivers in the form of cables or wires are used, and forcesfor articulating the end effector 502 is transferred from the actuator528 via tension only.

An alternate articulation mechanism is illustrated in the embodiment ofFIGS. 52E-52M. This articulation mechanism provides a doublearticulating wrist which enables articulation in first and secondopposite directions along a vertical axis, i.e., a yaw axis, and inthird and fourth opposite directions along a horizontal axis, i.e. apitch axis. Stated another way, in the orientation of FIG. 52Earticulation of the end effector can be effected in the up and downdirection (pitch up and pitch down) and the side to side direction (yawright and yaw left).

Referring initially to FIGS. 52E and 52F, the end effector 1142 of has amovable jaw 1146 and a stationary jaw 1148. The jaws 1146, 1148 can 1148can receive any of the other implants described herein. For example, ifthe implant 1010 is utilized as described below, for example, thefastener supporting member (and fasteners) would be in the moving jaw1146 and the receiver member would be in the stationary jaw 1148; if theimplant such as implant 10 is used by way of another example, then thefastener supporting member would be in the stationary jaw and thereceiver member would be in the movable jaw. It should also beappreciated that this double articulating wrist structure of FIGS.52F-FIG. 52M can be utilized in other surgical applicators and othersurgical devices where such articulation is beneficial, and not limitedto use with applicators having implants disclosed herein.

The double articulation enables movement about the yaw axis designatedby axis A1 and the pitch axis designated by axis A2. Note these two axesA1, A2 preferably intersect, and preferably intersect at a centralpoint. Such central intersection helps to ensure the pivot joint issecure in all positions and well defined, thus keeping the articulationwrist controllable. Additionally, because of the high tensile force offiring, preferably the drive cable bundle which effects movement of thedriver, e.g., driver 1147 to advance (deploy) the fasteners from thejaw, passes through the intersection of the axes A1, A2 Such placementreduces the chances of unwanted articulation, i.e., unwanted pitch andyaw movements, during advancement (firing) of the fasteners and/orretraction of the driver.

Preferably two pairs of tension ribbons are provided, the ribbonspreferably only under tensile load. One advantage of using ribbons isthey help keep the wrist controllable and are stiffer in comparison tocables or cords because of their lack of braiding. One pair of ribbons1150 a 1150 b effect pitch movement (referred to herein collectively aspitch ribbons 1150); another pair of ribbons 1152 a, 1152 b effect yawmovement (referred to herein collectively as yaw ribbons 1154). When oneof the pitch ribbons 1150 is pulled, it allows the other pitch ribbon1150 to extend so the wrist pitches about the pitch axis A2. When one ofthe yaw ribbons 1152 is pulled, it allows the other yaw ribbon 1152 toextend so the wrist pitches about the yaw axis A1. In order to minimizethe interaction of the two motions, the yaw ribbons 1154 preferablyattach to the jaws via rotatable joints in line with the pitch axis A2.

With continued reference to FIGS. 52E and 52F, the pivot 1160 isattached to the shaft yoke by fasteners 1162 and attached to the jaws1146, 1148 by fasteners 1164. The distal ends of the pitch ribbons 1150are attached to the pivot 1160 via pins or fasteners 1154 and as shownextend inside a slot 1161 in the pivot 1160. Note as viewed in theorientation of FIG. 52E, the pitch ribbons 1150 are spaced verticallyapart, each parallel to a longitudinal axis of the shaft 1140, with onepositioned above the other on each side of the longitudinal axis. Inthis manner, when the bottom ribbon 1150 a is pulled, the pivot 1160 ispivoted (rotated) clockwise about axis A2, e.g., the bottom portion ispulled so the top portion rotates toward the distal end as shown in FIG.52G. This can be considered a pitch down position, and the end effectoris 1142 is shown in this position in FIG. 52M. Conversely, when the topribbon 1150 b is pulled, the pivot 1160 is pivoted (rotated)counterclockwise, e.g., the top portion is pulled so the bottom portionrotates toward the distal end as shown in FIG. 52H. This can beconsidered a pitch up position and the end effector 1142 is shown inthis position in FIG. 52L. The distal end of the yaw ribbons 1152 areattached to the pivot 1160 at pins or fasteners 1154. Note as viewed inthe orientation of FIG. 52E, the yaw ribbons 1152 are spacedhorizontally apart, each parallel to a longitudinal axis of the shaft1140, with one positioned on each side of the longitudinal axis. In thismanner, when the ribbon 1152 a is pulled, the pivot 1160 is rotatedabout axis A1 to the left as shown in FIG. 52J. This can be considered ayaw left position. Conversely, when the other ribbon 1152 b is pulled,the pivot 1160 is rotated about axis A1 to the right as shown in FIG.52I. This can be considered a yaw left position. It should also beappreciated that both a yaw ribbon 1152 and a pitch ribbon 1150 can bepulled simultaneously to cause the end effector 1142 to both pitch andyaw, as shown by way of example in FIG. 52K, where pitch ribbon 1150 bhas been pulled to effect pitch up and yaw ribbon 1152 a has been pulledto effect yaw left. It should be appreciated that when one of the pairof pitch ribbons 1150 is pulled, i.e., tensioned, in a proximaldirection to effect pivoting, the other of the pitch ribbons 1150 isextended. Similarly, when one of the pair of yaw ribbons 1152 is pulled,i.e., tensioned, in a proximal direction to effect pivoting, the otherof the yaw ribbons is extended. Note the flexing of the pulled yawribbon 1152 shown in FIGS. 52I-52K. Note that up, down, top, bottom,etc. are used herein is with reference to the orientation of FIGS.52F-52M—if the orientation of the applicator changes, then thesereferences would change accordingly.

As noted above, the drive cable bundle for effecting movement of thedriver, e.g., the drive cables 544, 546 discussed above are containedwithin a flexible tubing 1165, composed for example of PTFE, althoughother materials are also contemplated. As discussed above the drivecable bundle passes through the intersection of the yaw and pitch axesA1, A2. The tubing 1165 helps to reduce friction at large jaw and/orlarge pitches while keeping the bundle passing through the intersectionof axes A1 and A2.

In addition to rotation and articulation of the end effector 502, thesurgical implant applicator 500 may be configured to perform additionalfunctions, such as transitioning the jaws between opened and closedconfigurations, actuating fasteners of an implant (e.g., the fasteners32 of the implant 10) disposed within the jaws 504, cutting surgicalstructures positioned between the jaws 504 proximate to the implant 10(e.g., cutting along the channel 124 of the implant 10 discussed above),etc. In one embodiment, the trigger 514 may be arranged with, or as partof, an end effector driving assembly or mechanism 540 to enable one ormore of the above functions of the end effector 502 to occur.

In one embodiment, the mechanism 540 may be arranged to cause actuationof a driver 542 of a drive assembly along the length of the jaws 504. Afirst tensioning member in the form of a first drive cable 544 and/or asecond tensioning member in the form of a second return cable 546 (FIGS.53A and 53B) may be connected to and transmit force from the endeffector driving mechanism 540 to the driver 542 (FIG. 53B). The cables544 and 546 may be any suitable wire, strand, string, rope, or otherelement capable of transferring tensile actuation forces. In otherembodiments, the cables 544 and/or 546, or other tensile elements, maybe connected to the upper jaw 504, the lower jaw 506 or other componentsof the end effector 502. The cables 544 and 546 in the illustratedembodiment are both connected between the mechanism 540 and the driver542 to enable movement of the driver 542 relative to the end effector502. Specifically in this embodiment, the drive cable 544 is arranged topull the driver 542 in the distal direction, while the return cable 546is arranged to pull the driver 542 proximally back to its initialposition.

According to the illustrated embodiment, each of the cables 544 and 546extends from a different one of a pair of drive spools 548 a and 548 b(collectively, “the drive spools 548”) of the mechanism 540 (positionedwithin housing 510) through the shaft 508, distally past the joint 516to the end effector 502 through a slot or opening 550 (FIG. 54B) in adistal end portion of the joint 516. The drive cable 544 continues alongand through a frame 552 of the jaw 504 b, through an opening, slot, orpassage 554 in the driver 542 (e.g., see the view in FIG. 54C) around apulley 556 (e.g., FIG. 55A) located adjacent the distal end of the jaw504 b, around a post 558 (e.g., see the bottom view in FIG. 53B) of thedistal driver 542, back around the pulley 556, back through the passage554 in the driver 542, and back through the opening 550 and the shaft508 to the drive spools 548 a. The return cable 546 is looped orthreaded around a post 560 extending between a pair of flanges 562 ofthe driver 542 and back through the opening 550 and the shaft 508 to thespool 548 b. Since each of the cables 544 and 546 in the illustratedembodiment forms a loop that starts and terminates at one of the spools548, it is noted that each of the cables 544 and 546 in this embodimentmay be arranged alternatively as a continuous belt or ribbon that doesnot have ends. One or more cable guides may be included in the housing510, e.g., a pair of cable guides 565 in the illustrated embodiment(FIG. 52C), to direct the cables 544 and/or 546 toward the driver 542and/or to keep the cables 544 and/or 546 away from the moving parts ofthe mechanism 540. It is noted that the cables 544 and 546 are shownonly in portion or not at all in some of the Figures for clarity of theother components of the applicator 500.

In the illustrated embodiment, the cables 544 and 546 are fastened totheir respective one of the drive spools 548 via one or more fasteners564 (FIG. 51D). That is, for example, the fasteners 564 each have a heador flange that is arranged to pinch or clamp the cables 544 and/or 546to the spools 548. The fasteners 564 may be any suitable bolt, screw,clamp, clasp, etc. In one embodiment, the cables 544 and/or 546 may bearranged with a knot, bulge, or protuberance that is locked to one ofthe spools 548. Alternatively or additionally, the cables 544 and/or 546may be formed similarly to a lasso (or double-sided lasso), with onlythe terminal end or ends of the cables 544 and/or 546 forming a loop forengagement with a post or fastener. It is to be appreciated that thecables 544 and/or 546 may be anchored, pinned, or otherwise secured tothe driver 542 without looping about the posts 560 and 562, such thatone end of each of the cables 544 and/or 546 terminates at the driver542 and an opposite end of each of the cables 544 and/or 546 terminatesat the corresponding one of the spools 548. For example, the posts 560and 562 may in one embodiment be replaced with fasteners similar to thefasteners 564. It is noted that each or either of the cables 544 and/or546 may be a multi-strand cable, either metallic or non-metallic, asingle fiber or wire, belt, or other equivalent elongated, flexiblemember having sufficient tensile strength and dimensions to perform thefunctions described.

As will be discussed in more detail below, the cables 544 and 546 can bearranged with the spools 548 such that rotation of the spools 548 in onedirection (e.g., counter-clockwise with respect to the embodimentillustrated in the Figures) causes tension on the drive cable 544, androtation of the spools 548 in the opposite direction causes tension ofthe return cable 546. For example, the drive cable 544 can be wrappedclockwise about the spool 548 a, such that counter-clockwise rotation ofthe spools 548 tightens the cable 544, and the return cable 546 can bewrapped counter-clockwise about the spool 548 b, such that clockwiserotation of the spools 548 tightens the cable 546. Due to the inclusionof the pulley 556, tension in the drive cable 544 urges or pulls thedriver 542 in the distal direction, while tension in the return cable546 oppositely urges or pulls the driver 542 in the proximal direction.In this way, rotation of the spool 548 in one direction causes thedriver 542 to travel distally along the jaws 504, while rotation of thespool 548 in the opposite direction cause the driver 542 to travelproximally along the jaws 504.

As noted above, the distal driver 542 is configured to perform multiplefunctions, including closing and opening jaws 504, cutting surgicalstructures located between the jaws 504 when the jaws 504 are in theclosed configuration, installing implants, e.g., the implant 10,disposed with the jaws 504, etc. In order to provide these functions,the device driver 542 may be movably or slidably mounted along a lengthof the end effector 502. For example, the device driver 542, as shown inFIGS. 54C and 55A, may include a bottom, lower, or first body portion568 that engages a lower surface of lower jaw frame 552 of the jaw 504 band a top, upper, or second body portion 570 that engages an uppersurface of the upper jaw 504 a In this embodiment, a rigid intermediatethird body portion 572 may extend between and connect the first andsecond body portions 568 and 570.

For example, the first, second and third body portions 568, 570, and 572may give the device driver 542 a shape that resembles an I-beamconfiguration, as shown best in FIG. 54C. The bottom body portion 568 ofdriver 542 may be slidably mounted on a set of rails 574 of the lowerjaw 504 b so that the driver 542 can be driven back and forth, e.g., viathe cables 544 and 546, reciprocally between a proximal end location,e.g., shown in FIGS. 54A-54C, and a distal end location adjacent thepulley 556, and proximal thereof, e.g., shown in FIGS. 55A-55C. The topbody portion 570 of the driver 542 is located on the top surface ofupper jaw 504 a when assembled (e.g., with respect to FIGS. 54A-55C, andcan best be seen in FIG. 55B) opposite the lower body portion 568 havingflanges or portions located above and/or below the rails 574. Forexample, as shown in FIG. 55A a transverse region at the bottom bodyportion 568 is positioned below rail 574 on both sides to assist inretaining the clamped jaws together as the driver 542 is advanced. Thefirst and second portions 568 and 570 may be, for example, one or moretabs, flanges, or other features dimensioned to prevent disengagement ofthe jaws 504 from between the first and second body portions 568 and570. A pair of slots 576 and 578 may be included in the upper jaw 504 aand the lower jaw 504 b, respectively, through which the intermediatebody portion 572 extends and along which the intermediate body portion572 of distal driver 542 slides or travels as the distal driver 542 istranslated distally and proximally relative to the jaws 504.

A blade, knife, cutter, or cutting implement 580 may be connected to,formed on, integral with, or otherwise form a part of a distal surfaceof third body portion 572 for purposes of severing tissue, implants suchas the surgical implant 10, and/or other surgical structures positionedbetween the jaws 504 and along the length of the slot 578. For example,cutting of surgical structures can be performed via the cutter 580. Forexample, as discussed above, if the surgical implant includes two ormore rows, e.g., the rows 35, of fastening subassemblies of implant 10along a length of end effector 502, the cutting implement 580 may bepositioned between the rows, such that the cutting operation with thedriver 542 acts to sever the installed surgical implant, and thecorresponding surgical structure on which the implant is installed, intotwo portions, one on each side of the cut made by the cutting implement580 of the driver 542. In one embodiment, with specific reference to theimplant 10 being used with the applicator 500, the cutting implement 580severs the bridge 37, while in other embodiments the cutting implement580 does not travel down the entire length of the jaws 504, such thatthe bridge 37 at the distal end of the implant (see e.g., FIG. 1) orother connecting element between rows of the implant is not cut, leavingthe two rows attached at their distal portions. In one embodiment, forexample, the implant 10 has a length of about 60 mm, while the cuttingimplement 580 travels about 55 mm of this length.

It is noted that before cutting occurs, initial distal advancement ofthe driver 542 from the proximal end of the jaws 504 initially towardthe distal end, e.g., by drawing on the cable 544 (e.g., spooling ontothe spool 548 a while allowing cable 546 to lengthen (e.g., unspoolingfrom the spool 548 b), causes the jaws 504 to close, as shown in FIG.55B-55C. More specifically, the driver 542 draws the top jaw 504 atoward the bottom jaw 504 b by squeezing the jaws 504 between the topbody portion 570 and the flange of the bottom body portion 568 as thedriver 542 is distally advanced.

For example, as shown best in FIGS. 55B-55C, the top body portion 570 isinitially located in a curved or angled recess 582 of the jaw 504 a whenthe driver 542 is in its proximal position. The recess 582 includes adistal sloped surface 583 a and a proximal sloped surface 583 b. As thetop body portion 570 is moved distally against the distal sloped surface583 a (e.g., during initial movement of the driver 542 via the cable544), the top body portion 570 will press against the surface 583 a,forcing the jaw 504 a to rotate toward the opposite jaw 504 b, therebyclosing the jaws 504. Oppositely, moving the top body portion 570proximally against the proximal sloped surface 583 b (e.g., duringreturn movement of the driver 542 back to its initial position with thecable 546), the top body portion 570 will press against the surface 583b, forcing the jaw 504 a to rotate away from the opposite jaw 504 b,thereby opening the jaws 504. Additionally or alternatively to thesurface 583 b being pressed, a spring or biasing element 581 as shown inFIG. 56A may be included to urge the jaws 504 into their openconfiguration when the driver 542 is aligned with the recess 582. Inthis way, the jaws 504 can be transitioned between their opened andclosed configurations by moving the top body portion 570 of the driverdistally and proximally within the recess 582. In one embodiment, thejaws 504 are opened at an angle of about 30° to about 60°, andpreferably about 45°.

One or more shields 584 and/or 585 may be located on the upper and lowerjaws 504 a and/or 504 b, respectively. The shields 584 prevent anytissue or surgical structures from being positioned too deeply into thejaws 504, thereby ensuring that the cutter 580 of the distal driver 542does not encounter or cut tissue or other surgical structures untilafter the surgical implant, e.g., the implant 10, is installed via theapplicator 500. The cutting implement 580 does not travel past theshields 584 and/or 585 until the jaws have been fully closed by distaltravel of the driver 542.

In order to connect the halves of the surgical implant disposed with thejaws 504, e.g., the portion of the implant 10 supported in receivermember 12 and in deployment member 14, the driver 542 may include adriving ramp for each row of fastener subassemblies included by theimplant. For example, in the illustrated embodiment, the device driver542 has a pair of ramps 586 a and 586 b (collectively, “the ramps 586”),as shown in FIGS. 54C and 55A, corresponding to the rows 35 a and 35 bof the implant 10. It is noted that only one ramp is needed inembodiments in which the implant has only a single row of fasteners. Theramps 586 each include a sloped distal engagement surface 588, which isramped up to a peak 590, which may take the form of a flattened ornon-sloped section. During distal travel of the driver 542 along thejaws 504, the surfaces 588 of the ramps 586 engage against one or morepushers 592, corresponding to the number of fasteners of the implantbeing installed by the applicator 500 to sequentially advance thepushers and fasteners. For example, in the illustrated embodiment, thepushers 592 are arranged in two rows of ten pushers, corresponding tothe two rows 35 of ten fasteners 32 of the implant 10. Again, it isnoted that other numbers of pushers may be used in embodiments having animplant with a greater or lesser number of fasteners. Also, the pusherscan be configured to engage and advance more than one fastener at a timeso fewer pushers can be provided.

The pushers are arranged to engage and/or receive each fastener and/orcompressible tower of the deployment segments of the implant beingimplanted by the applicator 500. For example, the pushers 592 of theapplicator 500 include pockets 594 configured to receive the fasteners32 and the towers 30 of the deployment segments 28 of the deploymentmember 14 of the implant 10 therein, and preferably receive the base ofthe fastener 32 and the base of the tower 30. FIG. 56B is a longitudinalsectional view taken along line B-B in FIG. 56A and illustrates thepushers 592, each being aligned with one of the towers 30 of thesurgical implant 10. In this way, distal movement of the driver 542causes the pushers 592 to first engage, and then climb, the surfaces 588of the ramps 586. This causes the pushers 592 to push the fasteners 32toward the opposite jaw, e.g., the jaw 504 a, which is carrying thereceiver member 12 and/or receiving segments, such as the segments 20.The dimensions of the peak 590, the pushers 592, the towers 30, the legs36 of the fasteners 32, the distance between the jaws 504 when in theclosed configuration, etc. can be set with respect to each other suchthat when the pushers 592 reach the peak 590 of the distally advancingdriver 542, the pushers 592 displace the fasteners 32 (which compressesthe towers 30, as described above, a sufficient distance to cause orensure that the barbs 42 at the ends of the tips 40 of the legs 36 ofthe fasteners 32 engage with the retainer 44 in the receiving member 12and/or the receiving segments, e.g., the segments 20, held by the jaw504 a opposite thereto. The ramps 586 may include a proximal engagementsurface 596, sloping opposite to that of surface 588, which graduallyreturns the pushers 592 to their initial positions and enables thedriver 542 to be returned past the pushers 592 when the driver 542 ismoved proximally back to its initial position.

In one embodiment, the distal ramp surface 588 may rise at a smallerangle than the angle at which the proximal ramp surface 596 falls. Thus,during operation, the distal surface 588 drives each of the pushers 592at a more gradual rate than the rate at which the ramp 586 enables thepushers 592 to return to their initial positions via the proximalsurfaces 596. This may provide a more controlled driving of thefasteners 32 by the pushers 592 through the tissue or other surgicalstructure and into the opposite member, e.g., the receiving member 12 ofthe surgical implant 10, while more rapidly enabling the pushers 592 tomove away from the surgical implant 10 as the driver 542 is movedproximally. The peak 590 may be arranged as a substantially horizontal(non-sloped) surface that briefly sustains a maximum driving force ofthe driver 542 and the pushers 592 against the surgical implant 10. Itis additionally noted in some embodiments that the proximal surface 596upon retraction will cause the pushers 592 to again be driven toward theopposite jaw, thereby potentially reapplying the actuation force to thefasteners 32, the towers 30, etc., which reapplication of force mayassist in creating a better seal or more secure connection with theimplant, and/or to provide a second opportunity to correctly fire anymisfired fasteners (e.g., to re-actuate any of the fasteners 32 whichdid not engage with the retainer 44 into engagement with the retainer44).

In view of the foregoing, it is to be appreciated that in one example ofoperating the applicator 500, once the jaws 504 have been located in adesired surgical target area and closed on the surgical target, thedistal driver 542 can be advanced distally along the length of the jaws504 by drawing on or shortening the cable 544 (e.g., spooling the cable544 about the spool 548 a) while simultaneously allowing cable 546 to bepulled and lengthened (e.g., unspooling the cable 546 from the spool 548b). The distal movement of the driver 542 will simultaneously installthe surgical implant 10, e.g., due to the pushers 592 engaging andclimbing the ramps 586, and cut the tissue or surgical structure clampedbetween the jaws 504, due to travel of the cutting implement 580 alongthe length of the jaws 504, in a single operation.

After completion of the connection of the implant halves (e.g., themembers 12 and 14 of the implant 10) together through the tissue orsurgical structure, thereby closing, securing, and/or sealing thesurgical structure with the implant, and cutting the surgical structure,the distal driver 542 may be returned proximally back along the jaws 504to its initial position at the proximal end of the jaws 504. The returnof the distal driver 542 may be driven by shortening the cable 546(e.g., by spooling the cable 546 about the spool 548 b) to cause pullingof the driver 542 in the proximal direction, while at the same timeallowing the cable 544 to be pulled and lengthened (e.g., by unspoolingthe cable 544 from the spool 548 a) to enable the return of the driver542 to its initial position.

In the alternate embodiment of FIG. 55D-55K, fastener pushers 592 arenot provided so the cam surface (ramp) 588′ of the driver 542′ of thedrive assembly contact the fasteners directly. That is, instead of theintermediate pushers 592 as in the above described embodiment whereinthe driver 542 contacts the pushers 592 which then contact the base ofthe fastener 32 to advance (deploy) the fasteners 32, the driver 542′directly engages the bend of the fasteners to advance the fastenerstoward the receiver member 12. This embodiment without the pushers 592is suited for example for use with the fasteners 800 of FIG. 44A andsuch fasteners are illustrated in these Figures. By elimination of theintermediate pushers, which are used to redirect the driver's distalmotion into transverse fastener motion towards tissue, the manufacturingcosts (parts and assembly time) are reduced and the risk of the pushersfalling out of the cartridge is eliminated.

As shown in FIG. 55D which illustrates an enlarged view of a portion ofthe stationary jaw, fasteners 800 are positioned so that the base 804 isaligned, i.e. parallel, to the longitudinal axis of the jaw 504′. Statedanother away, because the fastener bends 807 are perpendicular to thedriver cam surfaces 588′, the pushers 592 need not be provided. For easeof explanation, one of the fasteners 800 is shown in the advancedposition; the other fasteners are shown in the pre-fired (pre-advanced)position. The curved surface or bend (radius) 807 is directly engaged bythe cam surface 588′ as the driver 542′ is advanced distally to advancethe fastener 800. The opposing bend 807 is also directly engaged by theopposing ramp (cam surface) when the driver 542′ is retracted in theproximal direction. The driver 542′ can move in the same fashion asdriver 542, e.g., controlled by cables such as cable 544, 546, fordistal and proximal movement.

Cam surface 588′ of driver 542′ is composed of a compound curve. Thefirst curve 588 a on the distal surface reduces the force to start themotion, i.e., advancement, of the fastener 800, and the second curve 588b reduces the firing force during the final drive distance of thefastener 800. The initial and final fastener motion require the highestforce so the compound curve reduces the peak forces and thus reduces theoverall force to fire the fasteners. The proximal surface of the driver542′ has a camming surface 588 c which contacts the fastener 800 on theproximal return of the driver 542′ after completion of its distalmovement, thereby further driving the fastener 800 a greater distancefrom the jaw 504′.

Higher forces to push the fasteners through tissue or other structurerequire larger components to handle the higher stress and require theuser to apply more force to fire the fasteners. The configuration of thecamming surfaces 588 a, 588 b help reduce the force required to drivethe fasteners. The surfaces can have different curves than that shown tofurther adjust the firing forces. To further reduce the firing force,the fasteners 800, compressible members (e.g., towers 32) and/or thecartridge 902 supporting the fasteners can be coated with low frictioncoatings such as PTFE. Such coating on the fasteners 800 and/orcompressible members can for example reduce the friction between thecompressible members, e.g., towers 30, and the fasteners 800. Thecartridge material could also be varied and can include for exampleacetal, polycarbonate, nylon or other polymers with sufficient strength.The cartridge 901, supported in the deployment member, e.g. deploymentmember 14, can also include fastener guide features to help reduce thefiring forces. As shown in FIGS. 55F and 55G, the cartridge 901 includesU-shaped channels 904 formed in guides 902. As the driver 542′ isadvanced distally and retracted proximally, the camming surfaces 588 a,588 b and 588 c slide within the channels 904. Guide features 906 on theouter surface of the guides 904 abut the fasteners 800. As the driver542′ is advanced distally, and the cam surfaces 588 a, 588 b apply aforce to the bend 807 on one side of the fastener 800, the opposite sideof the fastener 800 slides against the cartridge guides 904, convertingthe driver force into fastener transverse, e.g., downward, motion. Thus,the bend 807 of the fastener 800 provides the fastener 800 withsufficient strength not to buckle from the driver cam surface 588′ onone side and the cartridge guide surfaces 906 which contact (abut) thefastener 800 help prevent buckling on the other side. The bends 807 ofthe fasteners 800 also have sufficient strength to keep the fastener 800from skewing and/or rotating in the cartridge guides and jamming. Suchstrengthening can be enhanced by making the bends wider and taller. Notethe bend 807 on the opposite side of the fastener 800 is contacted bycamming surface 588 c on the reverse (proximal) travel of the driver542′.

The movement of the driver 542′ to advance the fasteners 800 can best beappreciated in FIGS. 55J and 55K. These Figures show two of thefasteners 800 advanced (fired), one fastener 800 partially advanced andone fastener 800 not yet fired, i.e., in the pre-fired or pre-advancedposition. The two proximal fasteners 800 in FIGS. 55J and 55K have beenadvanced (deployed) by the distal advancement of the driver 542′ as theyare shown advanced from the cartridge 901 (and jaw 504′) as the cammingsurface 588′ has passed beyond their curve (bend) 807 and base 804. Thethird fastener 800 has already been contacted by the camming surface 588a and is shown engaged directly by the camming surface 588 b, whichcontinues to directly engage the curve (bend) 807 in fastener 800. Thus,this fastener 800 is not yet fully advanced by the camming surface 588′.(Note the relative positions of the fastener tips 806 of the variousfasteners 800). The distalmost fastener in FIGS. 55J and 55K is in theinitial position and not yet contacted by the camming surface 588′. Whenthe driver 542′ is further advanced (not shown), camming surface 588 awill contact bend 807 of this distal fastener 800, followed by contactof camming surface 588 b to further advance the fastener 800. After fulldistal advancement of driver 542′ to advance all the fasteners 800, themotion of the driver 542′ is reversed in the manner described hereinwith regard to driver 542 so that camming surface 588 c can furtheradvance the fasteners 800 into engagement with the receiver member,e.g., the retainer member 44 within the receiver member (e.g., receivermember 12). Note the advancement of the fasteners 800 will compress thetowers (not shown) in the manner described herein and the extent ofadvancement can be dependent on tissue thickness. Further note that onlya few of the fasteners are shown in FIGS. 55J and 55K for ease ofexplanation. In FIGS. 55D-55K, two parallel rows of the fasteners 800are provided with a central channel 905 between the rows to accommodatepassage of the driver and optional knife, however, in alternateembodiments, a single row or a greater number of rows of fasteners canbe provided. Thus, in the illustrated embodiment of FIGS. 55D-55K, twodrivers 542′ are provided on each side of the driver assembly, each withcamming surfaces on the distal and proximal sides, i.e., cammingsurfaces 588 a, 588 b and 588 c. As can be appreciated, if a differentnumber of rows of fasteners are provided, a corresponding number ofdrivers (and camming surfaces 588′) would be provided.

Referring back to FIGS. 51A-51D, the cables 544 and 546 pass into thehousing 510 of the surgical implant applicator 500 and connect to thespools 548 of the driving mechanism 540, as described above. The drivingmechanism 540 is operatively connected to the movable trigger 514 toenable a user to perform opening and closing operations of the jaws 504,installation of one or more surgical implants (e.g., the implant 10),cutting of tissue or surgical structures located between the jaws 504,etc., via manipulation of the trigger 514. The trigger 514 may be biasedto its initial position shown in FIGS. 51A-51D, e.g., via a spring orbiasing element 598, so that the trigger 514 returns to its initialposition after each pull of the trigger 514 toward handle 512 andsubsequent release of the pulling force.

The driving mechanism 540 includes one or more ratchet assemblies 600,each having a pair of ratchet gears or wheels 602 a and 602 b(collectively, “the ratchet wheels 602”) and a lock wheel 604. Thewheels 602 and 604 may be secured, fixed, locked, or integrally formedtogether such that they rotate in unison together. The trigger 514includes one or more drive pawls 606 rotatably mounted thereto that areengageable with the teeth of both of the ratchet wheels 602. As thetrigger 514 is pulled, the pawl 606 engages the teeth on both of theratchet wheels 602 in order to drive the ratchet wheels 602. That is,for example, the teeth of the ratchet wheels 600 are angled to permitmovement of the pawls 606 relative to the teeth in one direction, whilerotating the wheels 600 due to movement of the pawl 606 in the otherdirection. In the illustrated embodiment, pulling the trigger 514 towardthe handle 512 causes the pawls 606 to grab the teeth of the wheels 602,rotating the wheels 602 (and the lock wheel 604) in the counterclockwisedirection with respect to the orientation shown in FIGS. 51A-51D. It isnoted that the driving mechanism 540 may include a second one of theassemblies 600 and of the pawls 606 located on the opposite side of afollower gear 608 (discussed below) that are arranged as mirror imagesto the assembly 600 and the pawl 606, and which function in essentiallythe same manner described above, thereby providing redundancy andbalance to operation of the mechanism 540. The mechanism 540 is shown inFIG. 57A with one of the assemblies 600 and with the drive spool 548 bremoved for clarity of the components of the mechanism 540 that may behidden in the other Figures.

The assembly 600 may include an interlock 610, shown best in FIGS.57B-57C, which has a protrusion 612 that engages or catches a lip orshoulder 614 of the trigger 514 to lock trigger 514 relative to ratchetwheels 602. The interlock 610 in combination with the pawl 606 causesthe trigger 514 and the ratchet wheels 602 to move in unison in bothdirections of movement of the trigger 514, until the interlock 610 isreleased. For example, as discussed in more detail below, the interlock610 may be spring-loaded such that it can be pushed away from thetrigger 514, removing the interference between the lip 614 of thetrigger 514 and the protrusion 612 of the interlock 610.

The trigger 514 is shown in its initial position in FIGS. 51A-51D and ina first or intermediate actuation position in FIGS. 58A-58D. The drivemechanism 540 may include a safety mechanism 616 that includes a pin,shaft, or rod 618 extending laterally into or through the housing 510that is arranged to encounter a shoulder 620 of the lock wheel 604 inorder to block or prevent the trigger 514 from rotating further towardand closer to the handle 512. For example, the lock wheel 604 mayinclude a scalloped portion to create the shoulder 620, or the shoulder620 may be formed as a protrusion extending radially outwardlytherefrom. Moving the trigger 514 between its initial (e.g., FIGS.51A-51D) and first actuation positions (e.g., FIGS. 58A-58D), causesrotation of the wheels 602 and 604, as described above, and due to thepawl 606 and the interlock 610, the ratchet assembly 600 moves in unisonwith the trigger 514 as it travels back and forth between its initialposition and the first actuation position.

Rotation of the assemblies 600 causes corresponding rotation of thefollower gear 608. For example, the follower gear 608, located betweenthe pair of the assemblies 600 in the illustrated embodiment, may be inoperable communication with the assemblies 600 via a dowel 622 thatextends between the assemblies 600. Namely, a portion of dowel 622 mayextend through and be translatable along a cam slot 624 formed in thefollower gear 608. For clarity, the outline of the follower gear 608,including the slot 624, is highlighted in FIGS. 51D, 58D, 59D, and 60Dto show the relative location of the dowel 622 in the slot 624 as theapplicator 500 is operated through its various stages. By use of theslot 624 and the dowel 622, as the trigger 514 is moved toward thehandle 612 and the ratchet wheels 602 are correspondingly rotated due tothe engagement of the pawl 606 with the teeth of the wheels 602 (e.g.,rotated in the counterclockwise direction, with respect to theorientation shown in FIGS. 51A-51D and 58A-58D), the dowel 622 drawsagainst the slot 624 and drives the follower gear 608 to rotate about apin 626 connected to the housing 510 (e.g., also in the counterclockwisedirection, as shown in FIGS. 51A-51D and 58A-58D).

The follower gear 608 includes teeth that mesh with corresponding teethof a gear 628. The gear 628 is fixed relative to the spools 548 to causethe spools 548 to rotate about a pin or axle 630. As noted above,rotation of the spools 548 causes the cables 544 and 546 to be spooledand/or unspooled therefrom in order to move the driver 542 along thelength of the jaws 504. The rotation of trigger 514 thereby causes theassemblies 600 to rotate, which in turn causes rotation of the followergear 608, which drives the spools 548 to spool and unspool the cables544 and 546, and ultimately controls movement of the driver 542 alongthe jaws 504. In one embodiment, the initial position of the trigger 514may accordingly be set to position the driver 542 in its initialposition at the proximal end of the jaws 504, with the top body portion570 located in the recess 582. Accordingly, moving the trigger 514 toits first actuation position may cause the driver to be moved a limiteddistance distally and drive the top body portion 570 against the surface583 a, such that the first actuation position of the trigger 514corresponds to the closed configuration of the jaws 504. Similarly,releasing actuation force on the trigger 514 and permitting the trigger514 to return to its initial position (e.g., under the force of thebiasing member 598), may cause the driver 542 to be moved proximallyback to the initial position, causing the top portion 570 to encounterthe surface 583 b, thereby reopening the jaws 504. In short, moving thetrigger 514 between its initial position and its first actuationposition may be used in the illustrated embodiment to open and close thejaws 504.

As noted above, the safety mechanism 616 is provided to establish afirst actuation position for the trigger 514 and prevent the trigger 514from moving further toward the handle 512 from the first actuationposition. In this way, before the safety mechanism 616 is released orunlocked, the safety mechanism 616 enables the operator to easily andrepeatedly close and open the jaws 504, e.g., for purposes of locatingthe desired surgical target location prior to implanting the surgicalimplant 10 and cutting tissue or other surgical structures, as discussedabove, without risk of prematurely fully actuating the driver 542. Thatis, for example, the safety mechanism 616 can prevent the driver 542from being distally moved to a location at which the ramp 586 engagesthe pushers 592 and/or at which the cutting implement 580 is moveddistally beyond the shields 584 and/or 585, until implant installationand/or cutting operations are desired.

The rod 618 extends through and protrudes out of both sides of thehousing 510 of proximal assembly 506, thereby enabling the rod 618 to beactuated from either side of the applicator 500. The safety mechanism616 can be switched off, disabled, unlocked, or released by pushing inthe rod 618 into the housing 510 from either side of the housing 510.The rod 618 may be biased toward its initial, locked, or safety positionby one or more biasing members 634, such as springs, such that thesafety position is the default. The rod 618 includes larger diameterportions 636 and smaller diameter portions 638 (FIG. 57A) Actuation ofthe rod 618 out of the safety position causes the smaller diameterportions 638 to become aligned with each of the shoulders 620 (FIG. 57C)of the lock wheels 604.

The lock wheel 604 may be fixed relative to ratchet wheels 602, whichare fixed relative to each other. In the safety mode, the largerdiameter portions 636 are aligned with the shoulders 620, so that theshoulders 620 contact and abut against the portions 636 to limitrotation of the lock wheels 604 and therefore the entirety of theassemblies 600 as noted above. By moving the rod 618 in order to turnthe safety off, the smaller diameter portions 638 are aligned with theshoulders 620, enabling the shoulders to rotate past the rod 618,thereby enabling the assemblies 600 to be fully rotated. As noted above,in the safety mode, the trigger 514 can advance the ratchet gears 602only so far as the point where shoulder 620 contacts the larger diameterportion 636 of the rod 618 of the safety mechanism 616, which limits theamount of take-up and let-out of the cables 544 and 546, consequentlylimiting the possible travel distance of driver 542.

When the shoulders 620 are aligned with the smaller diameter portions638, the trigger 514 is permitted to be pulled slightly closer to thehandle 512, into a second actuation position, which may also be referredto as the fully actuated position. The applicator 500 is illustratedwith the trigger 514 in the fully actuated position in FIGS. 59A-59D. Asthe trigger 514 is pulled closer to the handle 512, the wheels 602 arefurther rotated as the shoulders 620 pass the smaller diameter portions638. Additionally, the relatively larger diameter of the shoulder 620becomes positioned between the larger diameter portions 636 of thesafety rod 618, preventing the springs 634 from being able to return therod 618 to the safety position, thereby locking the rod 618 in positionto allow firing (installation of the implant and cutting).

Once the jaws 504 have been positioned as desired, and the safetymechanism 616 is released, the operator of the applicator 500 can directfurther operations of the end effector 502 using the trigger 514. Forexample, once the jaws 504 have been positioned as desired and closedover the surgical target area, the operator can further operate thesurgical implant applicator 500 to install the surgical implant(s) 10and/or cut tissue or other surgical structures. That is, for example,continued rotation of the trigger 514 can be used to actuate themechanism 540 and spool and unspool the cables 544 and 546 from thespools 548, which causes the driver 542 to traverse along the length ofthe jaws 504 and provides the implant installation and cutting functionsdescribed above.

The drive mechanism 540 may include one or more pawls 640 rotatablymounted to the housing 510 of the proximal assembly 506. Each of thepawls 640 is arranged, unlike the pawl 606, to engage only the ratchetwheel 602 a (and thus, not the wheel 602 b) of the correspondingassembly 600. The pawls 640 are configured to prevent reverse rotationof the ratchet wheels 602 after the wheels 602 are rotated by thetrigger 514. However, the wheel 602 a includes a cutout 642 (FIG. 51C),where no gear teeth are present. As can be seen by comparing FIG. 51C(in which the trigger 514 is in its initial position) and FIG. 58C (inwhich the trigger 514 is in its intermediate actuation position), thepawl 640 remains aligned with the cutout 642 during movement of thetrigger 514 between its initial and intermediate actuation positions.That is, the pawls 640 slide along the cutouts 642 during both forwardand reverse rotation of the ratchet wheels 602 when the trigger 514 isbetween its initial and intermediate positions, so that the trigger 514can be operated to repeatedly open and close the jaws 504 without thepawls 640 interfering.

After the safety mechanism 616 has been released, e.g., by pushing therod 618 toward the housing 510, further actuation of the trigger 514 toits fully actuated position will cause the wheels 602 to rotate suchthat the pawl 640 exits the cutout 642 and can engage with the teeth ofthe wheel 602 a. That is, the teeth of the wheel 602 a and the pawl 640are arranged to permit movement of the teeth relative to the pawl 640 inone direction (e.g., counter-clockwise due to actuation by the trigger514), but such that the pawl 640 will lockingly engage the teeth of thewheel 602 in the opposite direction. The engagement of the pawls 640between teeth of the ratchet wheel 602 a thereby prevents reverserotation of the ratchet wheels 602. In this way, repeated release andpulling of the trigger 514 to the fully actuated position incrementallyrotates the assemblies 600 as the pawl 640 engages with new teeth of thewheel 602 a. It is noted that instead of pulling and releasing thetrigger 514 multiple times, actuating the trigger 514 to its fullyactuated position may in one embodiment activate a motor to drive thespools 548.

As noted above, the mechanism 540 may include the interlock 610. Theinterlock 610 may be configured such that when the operator pulls thetrigger 514 further toward the handle 512 from the intermediateactuation position, a ramped portion 644 of the interlock 610 is drivenagainst a protrusion 645 of a raised portion 646 on the housing 510 orsome other component to which the wheels 602 are mounted (e.g., seeFIGS. 57B-57C, FIG. 57D, which illustrates one half of the housing 510,and FIG. 57E, which is a cross-section taken laterally through thehousing 510, the protrusion 645 of the raised portion 646, the interlock610, the assembly 600, and part of the follower gear 608). As theinterlock 610 is rotated so that the ramped portion 644 encounters theraised portion 646, the ramped portion 644 presses the interlock 610toward or into the assembly 600, thereby releasing the interlock 610 byremoving the interference or engagement of the protrusion 612 of theinterlock 610 with the lip 614 of trigger 514. For example, in FIG. 57E,it can be seen that the interlock 610 includes a spring or biasingmember 647 in a cavity 649, which enables the aforementioned release ofthe interlock 610. In this way, releasing the interlock 610 enables thetrigger 514 to rotate back toward its initial position, while theassemblies 600 are prevented from doing so due to the pawl 640.

At this stage, repeated pulling and releasing of the trigger 514relative to the handle 514 drives the ratchet wheels 602 in thecounterclockwise direction with respect to the orientation of FIGS.59A-59D. Continued actuation of the wheels 602 causes the follower gear608 to rotate due to the dowel 622 driving against the cam slot 624 ofthe follower gear 608. During a complete rotation of the wheels 602(e.g., incremental/partial rotation caused by a plurality of repeatedpulls and releases of the trigger 514), the follower gear 608 is firstdriven in the counterclockwise direction so that it drives the spools548 to take up the cable 544 and let out the cable 546. This drives thedriver 542 from its initial or proximal location (e.g., see FIGS.54A-54C) to its distal position (e.g., see FIGS. 55A-55C). During distaltravel of the driver 542, as described above, the driver 542progressively actuates the pushers 592 the fasteners 32 to piercethrough the tissue and/or other surgical structures located between thejaws 504, and secure the halves, e.g., the receiver member 12 and thedeployment member 14, of the implant together. Simultaneously, as alsodescribed above, the cutter 580 progressively cuts through the tissueand/or other surgical structures.

FIGS. 60A-60D show the orientation of the mechanism 540 after thetrigger 514 has been pulled a sufficient number of times to fullyactuate the driver 542 distally and position the driver 542 at thedistal end of the jaws 504. When in the configuration of FIGS. 60A-60D,the dowel 622 has just crossed a mid-point of the slot 624. When therotation of the ratchet wheels 602 reaches the orientation where dowel622 reaches approximately the mid-point of the slot 624, continuedrotation of the ratchet wheels 602 causes the dowel 622 to drive thefollower gear 608 in an opposite direction, e.g., clockwise with respectto the orientation of FIGS. 60A-60D. By driving the follower gear 608 inthe opposite direction, the direction of rotation of the spools 548 isreversed so that the cable 544 is taken up by or spooled onto the spool548 a and the cable 546 is let out or unspooled from the spool 548 b.This drives the distal driver 542 back to its initial position andcauses the jaws 504 to reopen, e.g., by the top body portion 570pressing against the sloped surface 583 b of the recess 582.

In one embodiment, it takes six pulls of the trigger 514 to drive thedriver 542 from the initial position of FIGS. 51A-51D and 54A-54C to thedistal position of FIGS. 55A-55C and 60A-60D. In one embodiment, ittakes two more pulls of the trigger 514 to drive the driver 542 back tothe initial position from the distal position. A different number oftrigger pulls for advancing and/or retracting the driver are alsocontemplated. Also contemplated is a single pull of the trigger toadvance the driver its full distal distance. As the shoulders 620 of thelock wheels 604 come out of alignment with the rod 618, the interferencebetween the shoulders 620 and the rod portions 636 is removed, and thesprings 598 are able to return the rod 618 back to the safety position,thereby resetting the safety mechanism 616 and preventing the trigger514 from being moved beyond the intermediate actuation position untilthe safety mechanism 616 is again released. Likewise, when driver 542 isreturned to its initial proximal position, the wheels 602 are orientatedsuch that the housing pawls 640 are aligned again with the cutouts 642.Also, the angular position of the assembly 600, in the fully returnedposition, causes the interlock 610 to be out of alignment with theraised portion 646 and therefore no longer held in a depressed position.Thus, the interlock 610 is able to spring or move back out to causeengagement of the protrusion 612 with the lip 614 of the trigger 514. Inthis configuration, the surgical implant applicator 500 is fully resetand ready to be loaded with another surgical implant 10 if desired. Theapplicator can be designed for single use where it is utilized for asingle firing of the implant into the tissue or other structure.Alternatively, it can be designed for multiple firings in a singlepatient with fresh implants inserted into the jaws and applied to thetissue or other structures.

FIGS. 60E-60L illustrate a handle release mechanism or handle releasesystem that can be utilized with the handle/actuator mechanismsdisclosed herein. The handle release mechanism allows the jaws to berepeatedly open and closed to repeatedly clamp and unclamp tissue orother structure before transitioning to the fastener applying mode(cycle), where the jaws cannot be opened until the fastener applying(firing) cycle is completed. The release mechanism also provides asafety to prevent unintentional firing of the fasteners. The foregoingis achieved with an easy to use and easily accessible safety on thehandle.

The handle release system of FIGS. 60E-60L is configured to work withthe above described pull/pull systems and therefore the cables, pulley,ratchet wheels, spools, etc. are not described herein again. The systemis also designed to work with the applicator (device), e.g. applicator500, and jaws, e.g. jaws 504, for applying the various implants, e.g.implant 10, described herein and therefore the jaws and implant are notdiscussed again or shown in the drawings. However, it should also beappreciated that the handle release system of this embodiment can beused with applicators designed to apply fasteners or components otherthan the implants described herein.

Turning initially to FIG. 60E, the safety (or release) of the handlerelease mechanism (system) is designated generally by reference numeral1170. Safety 1170 is positioned on movable handle (or trigger) 1176 andoperatively associated therewith. The movable handle 1176 is movabletoward and away from stationary handle 1178 and is biased in a clockwisedirection. Safety 1170 has a hook or latch 1174 engageable with a hookreceiving member illustratively in the form of a recess 1180 instationary handle 1178. Safety 1170 further has a safety button 1172,positioned on the movable handle 1176, e.g., under the index finger ofthe user when the handle is grasped, for ease of access, which isselectively movable (pressible) by the user to an intermediate position,e.g., partially pressed or half pressed, as in FIG. 60G, and to a fullypressed position as in FIG. 60H. In the engaged position of the hook1174 and recess 1180 as illustrated in FIG. 60F, the hook 1174 catchesthe handle 1178 and holds the movable handle 1176 in this position withthe jaws closed such that the movable handle 1176 cannot be opened,i.e., returned to its initial position, and therefore the jaws cannot beopened. Thus, the jaws are held closed until the safety button 1172 ispressed. When the safety button 1170 is partially pressed to a firstrelease (intermediate) position, it pivots the hook 1174 out ofengagement with the recess 1180 as shown in FIG. 60G to enable thehandle 1176 to be returned to the initial position of FIG. 60E to reopenthe jaws. However, in this partially pressed position, the movablehandle 1176 cannot be actuated, i.e., further squeezed, to initiate thefastener firing (advancement) due to the abutment surface 1179 blockingan outer portion of the hook 1174. When the safety button 1172 is fullypressed (to a second release position), the hook 1174 moves away fromthe wall 1179 (FIG. 60K), releasing the movable handle 1176 for furthermovement to actuate the drive assembly to fire (advance) the pluralityof fasteners. The safety button 1172 is preferably biased clockwise by acompression spring to an extended (non-pressed) position. Note themovable handle 1176 is preferably biased distally by a tension spring(not shown) to the position of FIG. 60E. A handle ratchet 1182 is biasedin a counterclockwise direction into engagement with the ratchet wheel1184. In the position of FIG. 60E, handle (trigger) catch 1175 is lockedto ratchet wheel 1184 for forward driving and ratchet wheel snap 1190 islocked to the movable handle 1176 for reverse driving. With the movablehandle 1176 in the closed position of FIG. 60F, the handle ratchet 1182is disengaged from the ratchet wheel 1184 to allow reverse movement ofthe movable handle 1176 to allow jaw opening if needed. With the safetybutton fully pressed, the handle ratchet 1182 reengages the ratchetwheel 1184 and disables the reversing ratchet wheel and a protrusion1189 (FIG. 60K) on the inside of the handle presses the ratchet wheelsnap 1190 inwardly to disengage the ratchet wheel 1184 from the movablehandle 1176 to disable reverse driving. When the handle ratchet 1182 isengaged with the ratchet wheel 1184, then the movable handle 1176 caneffect firing of the fasteners. Note the outer wall 1188 of the ratchetwheel 1184 (FIG. 60L) keeps the safety button 1172 depressed until thefiring cycle is completed. The safety button 1170 is advantageouslysolidly positioned between movable handle 1176 and the stationary handle1178 so as to be sufficiently strong to tolerate full hand strength.

Turning now to the use of the release mechanism, in the open position ofFIG. 60E, movable handle 1176 is spaced from stationary handle 1178 andthe instrument jaws are in the open position as in the aforedescribedembodiments. In this open position of the movable handle 1176, releasebutton 1172 is in the extended (non-pressed) position, biased clockwiseby a compression spring, and hook 1174 of safety 1170 is out ofengagement with recess 1180 of stationary handle 1178. As noted above,movable handle 1176 is biased to the open position by a tension spring.Also, in this position, handle ratchet 1182 is engaged with ratchetwheel 1184, handle catch 1175 is locked to the ratchet wheel 1184 forforward driving and the ratchet wheel snap 1190 is locked to the movablehandle 1176 for reverse driving. When the movable handle 1176 is movedfrom its initial position toward stationary handle 1178 to the closedposition (FIG. 60F) to transition the jaws to the closed position, thehandle ratchet 1182 is disengaged from the ratchet wheel 1184 to allowreversing to reopen the jaws, i.e., movement of the movable handle 1176back to the open position of FIG. 60E, if the user desires to reclampthe tissue or other structure. Note the hook 1174 of safety button 1170engages the recess 1180 of the stationary handle 1178 to catch and lockthe movable handle 1176, and thus the jaws, in the closed position. Ifthe user wants to reopen the jaws to change the position of theinstrument and/or reclamp, safety button 1172 of safety 1170 is pressedpartially inwardly, i.e., into the movable handle 1176, to anintermediate position. This releases the hook 1174 as shown in FIG. 60Gso the movable handle 1176 can be pivoted distally (clockwise) back toits at rest position of FIG. 60E. However, movable handle 1174 cannot bemoved proximally in a fastener deploying motion to initiate the fastenerapplying (firing) cycle because the hook 1174 is in abutment with wall1179 of the stationary handle 1178. If the user does not wish to reopenthe jaws, then the user can proceed with the steps for deploying thefasteners. Once the jaws are closed to the position of FIG. 60F, tobegin the fastener firing cycle, the safety button 1172 is fullydepressed as shown in FIG. 60H, moving the hook 1174 out of engagementwith wall 1179, thereby freeing movable handle 1176 for proximalmovement. The handle ratchet 1182 reengages the ratchet wheel 1184,disabling reversing of the ratchet wheel 1184. The protrusion 1189 onthe inside of the handle (FIG. 60K) presses the ratchet wheel snap 1190inwardly, disengaging the ratchet wheel 1184 from the movable handle1176, disabling reverse driving. The jaws cannot be open once thisfastener deploying movement has commenced. Movable handle 1176 springsforward as the handle catch 1175 skips over the teeth of the ratchetwheel 1184 as the ratcheting cycle starts (FIG. 60I), with outer wall1188 of ratchet wheel 1184 keeping the safety button 1182 depressed.Note the handle ratchet 1182 remains engaged to the ratchet wheel 1184to prevent reverse motion. The movable handle 1176 is squeezed, i.e.,moved proximally, as shown in FIG. 60J to begin the cycle to deploy(fire the fasteners). Note the trigger catch 1175 engages the ratchetwheel 1184 add drives the ratchet wheel 1184 counterclockwise to firethe fasteners. Also the ridge 1188 of the ratchet wheel 1184 holds thesafety button 1172 retracted until the firing cycle is complete. Thepull and release of the movable handle 1174 is repeated until theratchet 1182 has made a complete rotation, firing the fasteners.

In one embodiment, the halves of the implant (e.g., the receiving member12 and the deployment member 14 of the implant 10) are directly loadedinto the jaws of an applicator (e.g., the jaws 504 of the applicator500) and supported (mounted) within the jaws. In one embodiment, one ormore of the halves are pre-loaded into a loading assembly or loader,which is then loaded into and supported by the jaws. For example, FIGS.61A-61C illustrate the deployment member 14 of the surgical implant 10preloaded into a loader or loading assembly 650 before the loadingassembly 650 is loaded into the jaw 504 b. In the embodiment of FIGS.61A-61C, the loading assembly 650 comprises a carrier 652 and thedeployment member 14 of surgical implant 10. Carrier 652 may be made ofpolycarbonate, acrylonitrile butadiene styrene (ABS) plastic, or othersufficiently strong polymer, for example. The pushers 592 may optionallybe included in the loading assembly 650, or alternatively carried by thejaw 504 b. It is noted that other implant halves besides the deploymentmember 14, e.g., the receiver member 12, may be loaded into loadingassemblies according to other embodiments of the present invention.Additionally, if practical, the entire implant, e.g., a hinged implant1010 in FIG. 77 having the members 12 and 14 connected by a hinge 1012,but which otherwise resembles the implant 10 discussed above, may be soloaded.

The loading assembly 650 may be loaded into the jaw 504 b by insertingproximal end portions 654 of the carrier 652 beneath a corresponding setof holding features 656, such as hinges, hooks, shoulders, ledges,projections, or the like, provided in the frame 552 of the jaw 504 b(e.g., see FIGS. 54B and 61A). Near its distal end, the carrier 652includes a pair of slots 658 and a recess 660 (FIG. 61B), which arecomplementarily arranged to receive a shaft 662 of the pulley 556 andthe pulley 556, respectively. After engaging the proximal end portions654 of the loading assembly 65 with the holding features 656 of the jaw504 b, the distal end of the carrier 652 is attached to jaw 504 b with asnap fit of shaft 662 into the slots 658 by pressing the distal endportion of the loading assembly 700 against the jaw 504 b. Duringinstallation of the loading assembly 650, the carrier 652 may initiallybe positioned with the end portions 654 located beneath the holdingfeatures 656 and with the carrier 652 at an angle relative to the jaw504 b (e.g., preferably an angle of about 15° to 30°, but the anglecould be smaller than 15° or larger than 30°), such that the engagementof the end portions 654 and the holding features 656 acts like a hingeto rotate the carrier 652 about the holding features 656 when pressingdown on the proximal end of the carrier 652 in order to secure thecarrier 652 to the jaw 504 b.

Ribs or webbing of the implant held by the jaws 504 of the applicator500, e.g., the ribs 23 and/or 29 of the implant 10, (see FIGS. 1 and 2)may facilitate alignment of the implant with the jaws 504, and form afriction fit between the surgical implant and the jaws 504, etc., tohelp retain the implant in the jaws against the force of gravity. Forexample, upon installation of the receiver member 12 of the surgicalimplant 10 into the upper jaw 504 a, ribs may be aligned and/or form acompression or friction fit with corresponding grooves 664 (FIG. 62D)formed in upper jaw 504 a. Likewise, the ribs 29 may be aligned and/orform a compression or friction fit with corresponding grooves 665 in thelower jaw 504 b. The jaw 504 a may additionally or alternatively includeopenings suitably arranged to align with and/or frictionally engage theshields 22 of the receiver member 12 of the implant 10. For example, thejaw 504 a in the illustrated embodiment includes a plurality of openings666 sized and spaced to align with and receive the shields 22 uponinstallation of the receiver member 12 with the jaw 504 a. A compressionfit formed between the members 12 and/or 14 and the jaws 504 may besufficiently strong to retain the halves of the surgical implant 10 inthe jaws 504 during the installation process, or other manners ofreleasable connection are possible, including adhesives, mechanicalfasteners, components, e.g., flanges or rails. The retention issufficient so jaws 504 initially support the halves e.g., members 12 and14, of the implant and then allow release from the jaws 504 due to thepassage of the driver 542 as discussed above.

The surgical implant applicator 500 is configured for the ability toinstall a sequence of two or more surgical implants 10 in a head-to-tailarrangement (e.g., a proximal end of a second one of the surgicalimplants 10 adjacent to a distal end of a first of the surgical implants10), if needed or desired. For example, in a situation where a targetsurgical site to be sealed and cut is longer than the length of theimplant, two or more of the implants can be installed in a head-to-tailarrangement in order to extend the length of the seal and cut resultingtherefrom FIGS. 62A-62D show portions of the jaws 504 and FIGS. 63A-63Eillustrate one example of a procedure wherein a first surgical implant10′ and a second surgical implant 10″ have been installed in a targetstructure 700. The implants 10′ and 10″ may exactly resemble the implant10 (or any of the aforedescribed alternate embodiments of the implant)discussed above, and are given prime and double prime symbols for thesake of clarity in discussion.

According to the method outlined in FIGS. 63A-63E, and with referencealso to FIGS. 62A-62D, a target surgical site 702 is first determinedfor establishing a seal or connection with the implants 10′ and 10″ andestablishing a location for a cut as indicated by a dashed line 704.Since the length of the target site 702 is longer than that of theimplants 10′ and 10″, the site is broken down into multiple sub-sites705 a and 705 b, equal to or less than the length of the implants 10′and 10″. FIGS. 63B and 63C illustrate the structure 700 after the firstimplant 10′ has been installed at the target sub-site 705 a and thetissue structure 700 has been cut between the rows of the implant 10′,enabling the cut and sealed portions of the structure 700 to separatefrom each other as shown in FIGS. 63C and 63D.

Next, as illustrated in FIG. 63D, the first implant 10′, after cutting,may be spread wide by the jaws 504 to part the cut portions of thestructure 700 away from each other. For example, as can be appreciatedin view of FIGS. 62A-62D, the shields 585 are sharply or acutely angledwith respect to the axis 520 of the jaws 504. As can be seen in FIG.62B, a gap 668 may be formed between the shields 585 and the nextimplant to be installed (e.g., the implant 10″). As shown in FIG. 62A,the distal end of the already installed implant 10′ may be positioned inthe gap 668 and the jaws 504 closed over the distal end of the implant10′ after the second implant 10″ is installed in the jaws 504. The angleof shields 585 causes the already installed implant 10′ to spread from afirst angle to a second angle larger than the first, and the portions ofthe cut tissue or other structure to widen, as illustrated in FIG. 63D.After positioning the implant 10′ in the gap 668 and closing the jaws504 and firing the driver 542 with the implant 10″ located at the targetsub-site 705 b, the structure 700 is again sealed and cut to separatethe structure 700 into discrete halves 700 a and 700 b, as illustratedin FIG. 63E. Cutting of the connected vertex of implant 10′ may occurduring the cutting of implant 10″ (as suggested by FIGS. 63A-63E), butmay alternatively occur during the cutting of implant 10′, or as anentirely separate step occurring prior to, after, or intermediate thecutting of implant 10′ and implant 10″.

In view of the above, it is to be appreciated that the presentdisclosure is directed to novel systems and methods for sealing and/orconnecting tissue and non-tissue structures using the surgical implant10 and other implants described herein, the applicator 500 and otherapplicators described herein, and the system 1000 and other systemsdescribed herein. In one exemplary method, the implant 10 is installedwith the surgical implant applicator 500. The method involves securingtogether one or more tissue portions via a surgical implant (e.g., thesurgical implant 10) such that thickness variations in the tissue aswell as wide tissue thickness ranges can be accommodated. Each half ofthe implant is brought into opposition through an applied clampingpressure generated by resilient and/or compressible members (e.g., thetowers 30), which results in a relatively constant and/or more uniformpressure distribution across the tissue contacting surfaces of theimplant, regardless of variations in tissue thickness, than would beexperienced by other types of fastening mechanisms, such as staples. Thesystem can be used to form a hemostatic seal of various types of tissueand tissues of varying thicknesses. That is, the application of theimplant forms a hemostatic seal without inducing an unacceptable degreeof necrosis of the clamped or adjoining tissue. By way of example, thesystem may be used to seal pulmonary parenchyma, or also used to sealthe pulmonary artery. In an exemplary embodiment, the method involvesloading the implant into an applicator (e.g., the applicator 500);positioning the applicator at the surgical site to join or seal one ormore tissue portions or structures; actuating the applicator to deployfasteners (e.g., the fasteners 32) and install the implant to form ahemostatic seal with or without the severing of adjoining tissue; anoptional step of resizing the length of the implant as needed; andanother optional step of resetting the applicator to deploy one or moreadditional implants. In some embodiments, the implant may already beloaded (i.e., pre-loaded) in the applicator such as in a situation inwhich the implant is loaded at the point of manufacture; in otherembodiments, the user loads the implant in the applicator. In a methodof fastening parenchyma by way of example, parenchyma is clamped betweenthe tissue contacting (engaging) surface on the fastener supporting(deployment) member 14 and the tissue contacting (engaging) surface onthe receiver member 12 and the fasteners (e.g., fasteners 32 or otherfasteners disclosed herein) are advanced into the receiver member 12,compressing the compressible members (e.g., towers 30) which then applya counterforce when the fastener supporting member 14 and receivermember 12 are coupled, by the fasteners, in the manner described above.In another example, an anastomosis between a first structure and asecond structure within the body is achieved utilizing the fasteners aredescribed herein to couple together the fastener supporting (deployment)member 14 which is positioned adjacent a first structure and thereceiver member 12 which is positioned adjacent a second structure.

In one example of use, an implant (e.g., the implant 10) is fittedwithin and secured to an end effector (e.g., the end effector 502) of animplant applier assembly (e.g., the applicator 500) such that adeployment member (e.g., deployment member 14 including, e.g., fasteners32 and towers 30) and a receiving member (e.g., the receiving member 12)are supported by and attached to one or both of a set of jaws (e.g., thejaws 504) and positioned for deployment. In one embodiment, each of thedeployment member and the receiver member of the implant is positionedwithin a removable carrier (e.g., the carrier 652) of a loading assembly(e.g., the loading assembly 650) that is received within a correspondingcavity or receptacle of the jaws. In another embodiment, the receivingmembers and the deployment member may be directly attached to the jawsat the point of use or manufacture. In an exemplary embodiment, theapplicator (e.g., the applicator 500) is inserted into the body with thejaws in the closed position using a minimally invasive procedureinvolving insertion of its end effector through a trocar or cannulahaving a diameter of about 5 to about 22 mm, more preferably, about 6 toabout 16 mm, and even more preferably about 12 mm. The user may activatethe articulation actuator and/or the rotation actuator to orient the endeffector (e.g., via the positioning assembly 518) at the desiredsurgical site, preferably with the jaws in the closed position. The jawsare moved to the open position and the receiving and deployment membersare positioned on opposite sides of the tissue defining a defect orother overlapping separate tissue portions such that when deployed, thetips (e.g., the tips 40) of the fasteners (e.g., the fasteners 32) areinserted through the tissue portions and a portion of the receivingmember. In other embodiments, it is contemplated that the tips of thefasteners arrive at opposite sides of the tissue without piercingthrough the tissue, e.g., located adjacent to the tissue or throughopenings in the tissue.

A user can then actuate a trigger (e.g., the trigger 514) to transitionthe jaws from the open to the closed position (configuration). Note thatin the illustrated embodiment, one of the jaws moves relative to theother jaw which is stationary jaw e.g., the jaw containing thedeployment member is stationary. It is also contemplated that the jawcontaining the deployment member could move relative to the jawcontaining the receiver member which remains stationary. It is alsocontemplated that both of the jaws could move relative to each towardand away from each other between open and closed positions as discussedabove. When closed, a user may then orient and move a safety mechanism(e.g., the safety mechanism 616 having the rod 618) in an unlockedposition to enable a driver or actuator (e.g., the driver 542) to slideor move along the length of the end effector. As the driver slides alongand over a dorsally facing surface of the jaws, the portion of jaws overwhich the driver slides may be further compressed together relative tothe natural position of jaws in its closed state. As the driver movesover portions of the jaws loaded with the deployment member, the drivermay engage and move one or more pushers (e.g., the pushers 592) towardsthe opposite jaw. The pushers in turn deploy the fasteners away from thedeployment member, through the deployment member, through one or moretissue portions and into the one or more receiver members oppositethereto. In this manner, the fasteners are fired and deployed along thelength of the implant as the driver moves from a first (e.g., proximal)end to a second (e.g., distal) end of the end effector.

The tissue secured between the deployment member and the receivingmember is clamped together at a constant, uniform, normalized, ordistributed pressure along the length of the implant sufficient to forma hemostatic seal that does not induce necrosis by virtue of thecompliant resilient, biasing, and/or compressible members (e.g., thetowers 30). As the properties of the tissue changes over time and/orchanges due to different environmental conditions, such as movement ofthe tissue and/or a build-up of pressure within the tissue, eachresilient, biasing, and/or compressible member (e.g., each of the towers30) may independently function to adjust for and otherwise accommodatethe localized pressure disturbance occurring within each fastenersubassembly of the implant (e.g., the subassemblies 34). This allows forthe implant to maintain a more normalized and/or substantially constantpressure for forming a hemostatic seal than otherwise would be availablewith other surgical fastener or stapling systems.

In one embodiment, the driver (e.g., the driver 542) includes a cuttingblade (e.g., the cutting implement 580) located in a channel formed inand through the end effector. The blade, which is preferably towards theside of the driver that moves towards the clamped tissue, may be securedto a body portion of the driver that causes and/or facilitatesmaintaining the jaws of fixed predetermined distance apart, and furthermay function to sever tissue and/or any intervening portions of theimplant encountered by the blade when moved along a channel along thelength of the jaws.

Upon reaching a second and/or distal end of the end effector, continuedactuation of the trigger induces the driver to return to the firstand/or proximal end of the end effector. The subsequent return of thedriver may function as a safety means for ensuring that all of thepushers and the fasteners are deployed along the entire length of theimplant. Once the driver is docked at the proximal end of the endeffector, the implant may be released from the jaws.

A user may then cut between the fastener subassemblies (e.g., throughthe ribs 23 and/or 29 of the implant 10) to remove any excess implantmaterial or otherwise alter the size of the implant. In other words, theimplant can be used on tissue lengths shorter than the implant itself.Additional implants may also be used to seal tissue sections longer thana single implant by directly adjoining the prior implant or mayotherwise be connected directly to the prior implant. A series of theimplants may be arranged to form a hemostatic seal as a stand-aloneprocedure or alternatively in conjunction with a tissue resectionprocedure. The aforementioned situations can allow a single or“standard” length of implant to be used on a variety of differentlengths or as different length rows.

As noted above, in an alternate embodiment, the deployment member(containing the fasteners) can be positioned on the movable jaw and thereceiver member positioned on the stationary jaw as an alternative tothe aforedescribed positioning of the receiver member on the movable jawand the deployment member (containing the fasteners) on the stationaryjaw. This embodiment is illustrated in FIGS. 78A-81D. It should beappreciated that this embodiment differs from the above describedembodiments, e.g., the embodiment of FIG. 50, in the differentpositioning of the deployment and receiver member of the implant and theresulting described changes as a result of this positioning. In allother respects, the implant, e.g. the retainer, the fasteners,compressible members, etc., and the applicator for applying the implant,e.g., the trigger, pulley, articulation, locking mechanisms, etc., arethe same as described herein, and the various embodiments of the implantand applicator described and illustrated herein can be utilized with theembodiment of FIGS. 78A-81D. For this reason, for brevity, the detailsof the applicator for use with the end effector of this embodiment arenot repeated herein since the function and components of applicator 500are fully applicable to this embodiment of FIGS. 78A-81D. Consequently,only the end effector assembly of this alternate embodiment isillustrated. Additionally, the implant 10 or other implants disclosedherein can be utilized with this embodiment of FIGS. 78A-81D, so forbrevity details of the implants, e.g., the fasteners, compressiblemembers, retainer, etc., are not repeated herein. The differenceregarding the implant is as noted above, the receiving part of theimplant is on the stationary jaw and the deployment part (fastenerreceiving/fastener supporting member) is on the movable jaw.

Placing the deployment member on the movable jaw instead of thestationary jaw has advantages in certain clinical applications whereadditional tissue dissection is desired. In certain applications, whenthe user is placing the jaws of the end effector around tissue, there islimited space to place the jaw around the backside as the target tissuestructure that is to be transected and sealed is connected to othertissue. Dissection of the target tissue from the other tissue can bedifficult without causing collateral damage to the tissue. Therefore,dissection of tissue is often minimized. With minimal dissection, incertain clinical applications, there is little space for the jaw toslide through. Since the jaw containing the receiver member (receiverjaw) is smaller than the jaw containing the deployment member (cartridgejaw) which supports the fasteners, the receiver jaw is the preferred jawto slide through the dissection opening. However, once this receiver jawis in place in the dissection, the user does not want to move the jawwhich could damage tissue. To keep this smaller receiver jaw stationary,the cartridge jaw would need to be the jaw that moves, e.g., pivots,towards the stationary receiver jaw for subsequent application of thefasteners. Thus, by placing the deployment member on the movable jaw,the smaller receiver jaw can fit through the minimal tissue space.

Turning now to FIGS. 78A-81D which show an embodiment of the deploymentmember (fastener supporting member) on the movable jaw, the end effectorof the applicator, e.g. applicator 500, is designated generally byreference numeral 1002 and has a movable jaw 1004 and a stationary jaw1006. Due to the illustrated orientation of the jaws 1004, 1006throughout the Figures, the movable jaw 1004 may be referred to hereinas the upper jaw, and the stationary jaw 1006 as the lower jaw, althoughit is to be appreciated that this is for the sake of discussion only andthat the jaw 1004 does not necessary have to be “above” the jaw 1006,i.e., after changing the orientation of the applicator. The stationaryjaw 1006 can have a width and/or height less than a width and/or heightof the movable jaw to provide a lower profile. FIGS. 78A, 81A and 81Cshow the end effector 1002 in an open configuration, with opposing firstand second portions of the surgical implant 1010, namely the receivermember 1012 and the deployment member 1014, mounted in the lower andupper jaws 1004, 1006, respectively. The end effector 1002 is at thedistal portion of the surgical implant applicator, such as applicator500, described above which includes a proximal assembly including ahandle assembly that is connected to the end effector assembly 1002 viaan elongated shaft (elongated portion) 1007 (only the very distal end isshown in FIG. 78A) extending therebetween. The shaft 107 can beidentical to shaft 508 described above. The proximal assembly includes ahandle portion like handle 512 of the aforedescribed embodiments toeffect operation of the end effector 1002, e.g., closing of the jaws1004, 1006, and advancement of the fasteners into the receiver memberand cutting tissue. The jaws 1004, 1006 may each have a distal angledsurface 994, 996 respectively with angles represented by curved lines990 and 992 respectively, angled away from each other such that when thejaws 1004, 1006 are brought into approximation, an angle 998 is formedthat opens towards a distal direction 988.

Lower receiver jaw 1006 has a pair of openings 1020, 1022 formed inupwardly extending ears 1024, 1026, respectively, (see e.g., FIGS. 79and 80C) to receive bosses (protrusions) 1030, 1032 of jaw armextensions 1034, 1036, respectively, of upper cartridge jaw 1004. (seee.g., FIG. 80B). The protrusions 1030, 1032 as shown extend inwardlytoward a longitudinal axis of the movable jaw 1004 and snap over theears 1026, 1024 of stationary jaw 1004 and into engagement with openings1022, 1020. Screw 1038 extends through opening 1040 on stationary jaw1004 and openings 1035 on movable jaw 1004 for attachment of the movablejaw 1004 to the stationary jaw 1006. Note that because the tension loadsare resisted by the moving jaw pivot, the pivot is under high loads. Thepivot is created by the protrusions 1030, 1032 engagement with theopenings 1022, 1020.

FIGS. 81A-81D illustrate schematically forces required to close the jaw1004. By placing the cartridge which supports the deployment member(which supports the fasteners) on the movable jaw 1004, the drive systemhas to work at a larger angle with respect to the longitudinal axis ofthe shaft 1007. That is, when the cartridge is on the stationary jaw,the drive system needs to work at most through the articulation angle A1of the end effector 1002. For example, if the end effector isarticulatable 60 degrees, the drive system would need to work throughthis 60 degree angle. However, assuming the movable jaw 1004 is open atan angle A2 to the stationary jaw 1006, when the cartridge is on themovable jaw, the drive system would need to work through an angle A1+A2.For example, if the articulation angle A1 is 60 degrees and the jawopening angle is 30 degrees, then the drive system would have to workthrough an angle of 90 degrees. Additionally, by placing the cartridgeon the movable jaw 1004, the pull-pull cable system described abovewhich fires (advances) the fasteners into the receiver member also needsto open and close the movable jaw 1004. To accommodate this, the pullforce that retracts the driver (and cutting blade when provided) needsto be on the opening side of the pivot of the movable jaw 1004. Thispivot is designated by reference numeral 1039 and for ease ofillustration is depicted as a solid black circle. The placement of thepivot 1039 creates a jaw opening moment which is shown by the linelabeled 1042. Thus, the pull force that causes the driver (and optionalblade) to move distally is below the moving jaw pivot 1039 so as tocreate a jaw closing moment during firing of the fasteners labeled asline 1043 in FIGS. 81C and 81D. Note that since the pull cables (similarto cables 544, 546) which move the driver distally and proximally needto make tight changes in direction which can cause additional friction,a PTFE O-ring and/or PTFE lubricants can be utilized to reduce friction.

The end effector assembly 1002 can in some embodiments have a relieftrack for the driver, as shown in the embodiment of FIGS. 82A-88C, inwhich the driver 1050 engages the stationary jaw 1006 to hold themovable jaw 1004 and stationary jaw 1006 closed during advancement(firing) of the fasteners, allows the jaws 1004, 1006 to open slightlyafter firing of the fasteners and pushes the jaws 1004, 1006 open uponretraction. The driver 1050 also resets after full retraction and isready to repeat the cycle if another implant is loaded in the jaws 1004,1006. The path of the driver 1050 is shown by the dashed line in FIG.82A which as can be seen travels along one plane in one direction andmoves along a second plane on its return in the other direction.

More specifically, stationary jaw 1006 has outer cam surfaces 1060 a,1060 b (collectively cam surface 1060) which extends longitudinallyalong most of its length. The cam surface 1060 (FIG. 82B) as shown isformed on each side of the slot 1005 of the stationary jaw 1006. Camsurface 1060 terminates proximally of the distal end of slot 1005.Driver 1050 has a tab 1054 on its lower surface (as viewed in theorientation of FIG. 82A). The tab 1054 extends laterally with respect tothe driver 1050 to create a wider width to engage the cam surfaces 1060a, 1060 b of stationary jaw 1006. That is, the tab 1054 is in the formof protrusions extending perpendicular to the direction of movement ofthe driver 1050. The cam surface 1060 ends just proximal of the distalend of the jaw 106, thus creating a gap or opening 1062 (FIG. 82B)dimensioned to allow the tab 1054 to drop through. That is, the width ofopening 1062 is greater than the width of tab 1054 so that when the tab1054 reaches opening 1062 it can fit through the opening 1062.Conversely, the width spanning camming surfaces 1060 a, 1060 b is lessthan the width of the tab 1054 so the tab 1054 cannot pass through thespace between the cam surface 1060 a, 1060 b, i.e., cannot pass throughthe slot 1005. Stationary jaw 1006 also has inner cam surfaces 1064 a,1064 b (collectively cam surface 1064) best shown in FIG. 85F. Camsurface 1064 is engaged by the tab 1054 after the driver 1050 hascompleted its distal travel, has moved through the opening 1062 in slot105 and begins its proximal travel. This engagement causes the jaws1004, 1006 to move to an open position. Note the opposite end of thedriver 1050 includes a tab 1052 which travels along an outer surface ofthe movable jaw 1004 to maintain the jaw 1004 in a closed position.

One advantage of the driver 1050 and relief track is that the driver1050 does not to be fully retracted past the jaw hinge point in orderfor the jaws 1004, 1006 to open. In configurations where the driver mustbe retracted past the hinge point before the jaws can open, abruptopening of the jaws can occur which can in certain applications causetissue damage. In this embodiment of FIG. 82A-88C, the jaws 1004, 1006open slightly when the driver 1050 finishes its distal travel and thusthe jaws are not in the fully closed position when the driver 1050 isretracted, i.e., moved proximally,

The operation of the driver 1050 is illustrated in FIGS. 83A-88C. FIGS.83A-83C illustrate the jaws 1004, 1006 in the open position with thedriver 1050 in the proximal position prior to initial advancement. Notethe tab or flange 1052 on the side of the driver 1050 opposite the sidehaving the tab 1054 engages an outer surface 1009, e.g., upper surfaceas viewed in the orientation of FIG. 83A, of the movable jaw 1004. Asthe driver 1050 moves distally past the hinge point, the movable jaw1004 is moved to a closed position as shown in FIGS. 84A-84C. Note thedriver tab 1054 is below the stationary jaw 1006 (as viewed in theorientation of FIG. 84C) and the tab 1052 of driver 1050 is above themovable jaw 1004 (as viewed in the orientation of FIG. 84C). Continueddistal motion of the driver 1050 is shown in FIGS. 85A-85C, where tabs1054 and 1052 continue moving along their respective jaws 1006, 1004, tohold the jaws 1006, 1004 closed. In FIG. 85C, driver 1050 has completedits distal travel to advance the fasteners from the cartridge withinmovable jaw 1004 (and transect tissue if a cutting blade is provided)and is entering opening 1062 in slot 1005 as the camming surface 1060ends, causing the driver 1050 to move from a lower plane (FIG. 85C) toan upper plane (FIG. 86C), as viewed in the orientation of FIGS. 85C and86C, so it no longer will be in engagement with the under (lower)surface 1013 of the stationary jaw 1006. (See also FIGS. 85D and 85Ewhich show movement of the tab 1054 along the camming surfaces 1060 inFIG. 85D and at the distal opening 1062 in FIG. 85E). When the driver1050 reaches this distal position, as shown in FIGS. 86A-86C, the jaws1004, 1006 can spring open. Note the compressed tissue and implant canpush the jaws 1004, 1006 apart to open slightly. The slight opening ofthe jaws 1004, 1006 causes the driver tab 1054 to push against thecamming surfaces 1064 a, 1064 b (collectively camming surface 1064)which are on the opposing surface or inner surface of the stationary jaw1006. Stated another way, the camming surface 1060 (FIG. 85E) is on theouter side of the stationary jaw 1004 to keep the jaws 1004, 1006 closedwhile the camming surface 1064 (FIG. 85F) is on the inner side of thestationary jaw 1006 to push the jaw 1006 open as the driver 1050 isretracted. Note as the driver 1050 retracts, it pushes the implant fromthe cartridge contained within the movable jaw 1004. The retraction ofthe driver 1050 back toward its initial proximal position is shown inFIGS. 87A-87C. As the driver 1050 approaches the proximal position, thejaws 1004, 1006 can be further opened, e.g. opened to about 25 degrees,although opening to other degrees is also contemplated, and the rubberspring 1056 is compressed. The cam surface 1064 of stationary jaw 1006ends just distal of the proximal position of the driver 1050, and as thedriver 1050 reaches its most proximal position and the cam surface 1064ends, the jaws 1004, 1006 are slightly closed by the spring 1056. Thissets the driver tabs 1054 back on the outer side of the stationary jaw1006 to reset for another cycle if another cartridge is loaded in themovable jaw 2004. FIGS. 88A-88C show the driver 1050 reset for anothercycle with the jaws 1004, 1006 in the open position.

As noted above, in certain embodiments, the surgical applicator can beloaded with a new implant and the new implant applied to the tissue ortissue structure. FIGS. 89A-96 illustrate an embodiment wherein a new(fresh) implant is loaded into the jaws of an applicator which has thedeployment member in the movable jaw and the receiver member in thestationary jaw as in jaws 1004, 1006 of FIG. 78A. More specifically,with initial reference to FIGS. 89A-89C, the reload assembly (alsoreferred to as the reload or loading assembly) is designated generallyby reference numeral 1100 and has a distal portion 1108 and a proximalportion 1110 with optional recesses 1119 located on its sides that maybe utilized to facilitate manual gripping. At the distal portion 1108,the reload assembly may have a distal angled surface 1117 that is at anangle (e.g., between 20 and 75 degrees) from a horizontal planeestablished by a top surface 1116 of the reload assembly. The reloadassembly includes a housing or carrier 1109 containing (supporting) animplant 1120. Implant 1120 is identical to implant 1010 of FIG. 78A inthat it as a deployment member 1124 designed for placement in themovable jaw and a receiver member 1126 designed for placement in thestationary jaw. The deployment member 1124 is identical to thedeployment member 1014 of implant 1010 in that it has, e.g., a pluralityof fasteners preferably arranged in at least one row parallel to thelongitudinal axis of the fastener supporting member, compressiblemembers compressible by the fasteners, etc. The receiver member 1126 isidentical to receiver member 1012 of implant 1010 in that it has, e.g.,a retainer, a plurality of shields, etc. Since the implant 1120 isidentical to implant 1010, for brevity it is not further discussedherein since the features and components and function of the implant1010 is fully applicable to the implant 1120. Note that although theloading assembly 1100 contains implant 1120, other implants disclosedherein can alternatively be loaded in the loading assembly 1100 toenable a user to load a desired implant and/or apply additional implantsto tissue or other structure.

As shown in FIGS. 89A-89C, the deployment member 1124 which contains thefasteners is on one side of the loading assembly 1100 and the receiverportion 1126 is on the opposite side of the loading assembly 1100 forplacement in the opposing jaws of the end effector assembly discussedbelow. The deployment member 1124 is mounted within a cartridge 1129which has a tab engaging slot 1125 (FIG. 91B) to engage tab 1113discussed below to first mount loading assembly 1100 to the movable jaw.The cartridge portion 1129 also has projections 1130 (FIGS. 93A and93B1) which form snap features to engage slots 1132 in the movable jaw1104 to retain the cartridge portion 1129 in the movable jaw 1104, alsodiscussed below. The receiver member 1126 frictionally engages thestationary jaw 1106 in the friction areas 1133 as shown in FIG. 95B.When the deployment member 1124 and the receiver member 1126 are engagedin the respective movable and stationary jaws 1104, 1106, the housing1109 of the loading assembly 1100 can be removed from the deploymentmember 1124 and the receiver member 1126. That is, separation of thehousing 1109 from the implant 1120 leaves a first portion of the implante.g., the deployment member 1124, in the movable jaw 1104, and thesecond portion of the implant, e.g., the receiver member 1126, in thestationary jaw 1106 (see FIG. 96). The transfer of the first and secondportions to the jaws 1104, 1106 and removal of the housing 1109 arediscussed below in the method of loading the implant into the jaws of anapplicator.

FIGS. 90-96 show the steps for loading the loading assembly 1100 intothe end effector 1103 of the applicator. The end effector assembly 1103has a stationary jaw 1106 and a movable jaw 1104. Movable jaw isactuable to transition the jaws 1104, 1106 between open and closedpositions. The end effector assembly 1103 is connected to the handleassembly of the applicator by shaft 1107 in the same manner as shaft1007 of end effector assembly 1002. The handle assembly (not shown) isactuable as described above to close the jaws 1104, 1106 and driver1112, which can have a jaw camming tab 1114 as in tab 1152 of driver1150 described above, is advanced distally in the same manner as driver1050 described above to deploy (advance) the fasteners from the movablejaw 1104 toward the receiver member 1126 in the stationary jaw 1106. Asshown in FIG. 90, the jaws 1104, 1106 are in the open position,connected at pin 1115, to provide a space to receive loading (reload)assembly 1100. The loading assembly 1100 is inserted between the jaws1104 with the cartridge side 1121 facing the open movable jaw 1104 (theupper jaw as viewed in the orientation of FIG. 90) and the receiver side1123 facing the stationary jaw 1106 (the lower jaw as viewed in theorientation of FIG. 90). As can be appreciated, if the orientation ofthe end effector assembly 1103 changes, the positioning of the upper andlower jaws will also change.

In the next step, the loading assembly 1100 is moved into engagementwith the jaw tab (or tabs) 1113 of the movable jaw 1104 (FIGS. 91A and91B) as the slotted region 1125 at the proximal end of the cartridgeportion 1129 is slid under the tab 1113. When the slots 1125 engage thetab 1113, the loading assembly 1100 is rotated by the user toward themovable jaw 1104, e.g., rotated upwardly toward the jaw 1104, from theposition of FIG. 90 to the position of FIG. 92. Note FIG. 91A shows theslot/tab engagement before the load assembly 1100 is rotated as in FIG.90; FIG. 91B shows the slot/tab engagement when the load assembly 100has been rotated as in FIG. 92. Also note in the position of FIG. 92,the load assembly envelops the movable jaw 1104 on three sides—lowerside and two sides. When the reload assembly 1100 is rotated to theposition of FIG. 92, the projections 1130, extending outwardly fromopposing sides of the cartridge portion 1129, are snapped into theelongated slots 1132 on opposing sides of the movable 1104 as shown inFIGS. 93A and 93B. This retains the cartridge portion 1129 in themovable jaw 1104. Subsequently, the handle trigger (not shown) isactuated to move the jaws 1004, 1006 to the closed position of FIG. 94,i.e., to move the jaw 1104 toward jaw 1106. The snap feature engagementof projections 1130 and slots 1132 holds the deployment member 1124 inthe movable jaw 1104 and the receiver member 1126 is frictionallyengaged in the stationary jaw 1106 at regions 1133 of FIG. 95B. Thusboth portions of the implant 120 are retained in the jaws 1104, 106.With the jaws 1104, 1106 held in the closed position, the housing 1109of the loading assembly 1100 is slid out from the jaws 1104, 1106 in adistal direction as shown in FIG. 95A. After removal of the housing1109, the trigger is released to move the jaw 1104 to the open positionas shown in FIG. 96 with the deployment member 1124 of implant 1120 heldin the movable jaw 1104 and the receiver member 1126 of implant 1120held in the stationary jaw 1106. The applicator is now ready foractuation to close the jaws around tissue or other structure and advancethe fasteners from the movable jaw 1104 into the receiver member 1126 inthe manner described above, including, if provided, the driver movementand relief track of FIGS. 82A-82C. Other mechanisms to close the jawsand advance the fasteners are also contemplated

It should be appreciated that this method of loading and/or reloading anapplicator of FIGS. 90-96 can be used to load other implants. Thus, theconcept of inserting a housing containing an implant between the jaws ofan applicator (instrument/device), closing the jaws to transfer theimplant to one or both of the jaws and free the housing for separationfrom the implant, and removal of the housing from the implant to leavethe implant in one or both of the jaws can be utilized to load or reloadvarious types of implants, fasteners, etc.

It should further be appreciated that one or more loading assemblies1100 may be presented for storage and eventual use in a one or moresterile configurations, including for instance: (i) individualpackage(s) 982 as sterile with a sterile barrier 981 encapsulating aloading assembly 1100 (see FIG. 97A), (ii) a plural package 983 ofloading assemblies 1100 in a single sterile barrier (see FIG. 97B), or(iii) a packaging band or strip 984, which may include one or both ofindividual packages (e.g., 982) or plural packages (e.g., 983) that areinterconnected. The band or strip may be able to be separated alongpredetermined separation lines 980, which may be constructed forinstance as perforations to provide a predetermined tear line or region.Sterility may be for example greater than or equal to 10{circumflex over( )}(−6) or 10{circumflex over ( )}(−3) SAL. As packaged, the loadingassemblies may be pre-loaded with the implants as taught for examplethroughout the present disclosure. Additionally, any of theaforementioned packages 982, 983, 984 may be pre-packaged in one or moreboxes 985 (see FIG. 97D), which may be configured according to implantsize, desired maximum or preferred implant tissue thickness, and/orimplant length.

Referring now to FIGS. 64-66 and 69, an implant 200 according to analternate embodiment of the present invention is shown. The implant 200includes a deployment member 202 and a receiver member 204. Thedeployment member 202 and receiver member 204 are of substantially thesame length and are configured and dimensioned to be connected insubstantial alignment to one another, on opposite sides of surgicalstructure to be closed, tacked, secured, or sealed by compressing thesurgical structure therebetween. The members 202 and 204 are configuredso that installation of the implant 200 on different thicknesses ofsurgical structures can be accomplished within the same implant 200, aswill be described in greater detail and generally akin to the implant 10discussed above. In the example shown, the implant 200 is being appliedto a vessel 205, e.g., a large pulmonary vessel of a patient, so as totransversely and completely seal off the vessel 205.

The base of deployment member 202, similar to the base 24 of thedeployment member 14, may in some embodiments be made of a soft,flexible material, preferably silicone rubber, but could, alternativelyor additionally be composed of one or more of other soft, biocompatiblematerial suitable for implantation, such as, but not limited topolyurethane, thermoplastic elastomer (TPE), natural rubber, latex,bio-absorbable polymers, etc. Deployment member 202 further includesclips, fasteners, or anchors 206, including those of the type describedabove, that are actuatable to be driven out of deployment member 202,through the tissue 205 and into a receiver or anchor base 208 inreceiver member 204. The anchor base 208 includes a retainer 210,generally resembling the retainer 44 (or its variants) discussed above.For example, the retainer 210 in the illustrated embodiment may includea layer of mesh or woven material embedded or molded in the anchor base208 of the receiver member 204, or is otherwise fixed to the main bodyof the receiver member 204. Similar to the retainer 44, the retainer 210may optionally be made of polyethylene terephthalate (PET),polyetheretherketone (PEEK), nylon, or other polymers, cotton, or otherfibrous materials, etc. A retainer similar to retainer 210 could also beprovided in the deployment member 202 in a similar fashion to some ofthe embodiments discussed above.

The anchor 206 may include fasteners in the form of one or more legs,shanks, or pins 212 arranged to be actuated through a surgical structureor tissue positioned between the deployment member 202 and the receivermember 204. The pins 212 may be made of stainless steel, titanium orother biocompatible metals, metal alloys, and/or rigid, biocompatiblepolymers. The pins 212 may extend from a base body 213. Each pin 212 isprovided with a series of barbs 214 that are spaced apart along a lengthof the pin 212. Optionally, the pins 212 and/or the barbs 214 may beover-molded by the material of the deployment member 202, e.g., siliconeor other soft polymer. As each pin 212 is driven toward the surgicalstructure e.g., tissue 205 and into the anchor base 208, each pin 212passes through one of the mesh openings 216 (see FIG. 65) and is drivenalong a distance determined by a predetermined driving force and thethickness of the tissue 205 that exists between the deployment member202 and receiver member 204 at the location of that anchor 206. Implant200 can be applied using the applicators described herein.

FIGS. 67-68 show alternate embodiments in which an anchor 218 and ananchor 219 comprise a pair of substantially parallel pins 220 and 221,respectively, each pair of pins having alternating barbs 222 that extendrespectively from a base 223 and a base 224 against which a driving oractuation force may applied to drive the anchor members 218 and/or 219.In this case, the two pins 220 and/or 221, when deployed pass throughtwo of the openings 216 in the anchor base 208. The barbs 222 alternatefrom side-to-side of the pins 220 and 221 so that no barb 222 istransversely aligned (along or parallel to a transverse axis 225 of thepins 220 and/or 221) with another barb 222 on the same pin. Note that inFIG. 67, the transverse axis 225 is aligned with a plane 226, but inFIG. 68, the transverse axis 225 is normal to the plane 226. As aresult, all barbs 222 are substantially in or parallel to the plane 226in FIG. 67, but in FIG. 68, the barbs 222 lie in planes normal to theplane 226. The use of two pins 220 and/or 221 may be beneficial in theseembodiments, e.g., for ease of manufacturing and to balance the piercingpressure so that the pins 220 and/or 221 pierce through the surgicalstructure along generally straight paths. In the examples shown in FIGS.67-68, the anchor 218, 219 may be stamped from stainless steel or othersuitable material and the pins 220 and/or 221 are bent at an angleperpendicular to the bases 223 and/or 224 of the anchors 218 and 219,respectively. Additionally, the barbs 222 of one of the pins 220 and/or221 are in a plane that is parallel to a plane in which the barbs 222 ofthe other pin lie. The anchors 218, 219 form part of the implant whichis otherwise the same as the aforedescribed implant of FIGS. 64-66, andcan be applied in a similar manner.

Alternative forms of barbs discussed herein are also contemplated. Forexample, the barbs 214, 222, (and 42), etc., that may be employedinclude, but are not limited to, forming the barb by piercing a “V” orother generally pointed shape into a base structure and bending the “V”or other shape outward; skive barbs formed by sliding a blade, or skive,along the structure and driving the blade into the structure, such ascommonly used for fishing hooks; micro barbs, e.g., barbs having aplurality of very small protrusions in the range of approximately 0.010″or smaller, etc. Further optionally, the pins 212, 220, and/or 221 maybe configured so that the free ends/distal tips 230 bend over afterdeployment to further secure the corresponding anchor from releasingfrom the retainer, e.g., the retainer 44 and/or 210. It is to beappreciated that any discussion of any component from one embodimentherein generally applies to like-components from other embodiments,whether or not the same name is used to refer to both (and in fact, withreference to some embodiments, different names are purposely used forlike-components from different embodiments for the sake of clarity indiscussing those particular components). For example, it is to beunderstood that similarly to the legs 36 of the fasteners 32, theanchors 206, 218, and/or 219 may include a single one of the pins 212,220, and/or 221, or any number thereof. Likewise, similarly to the pins212, 220, and/or 221, the legs 36 may be arranged to be bent over afterdeployment to further secure a surgical structure in place.

Referring back to FIGS. 64-66, as the pins 212 are driven to pierce thetissue 205, the distal tips pass through the tissue 205 (or othersurgical structure) and the openings 216 of anchor base 208 and/or theopenings of the retainer, to a depth that is dependent on the tissue (orsurgical structure) thickness through which each anchor 206 passes. Ifthe barbs 214 are alternatingly positioned along the length of the pinas described above with respect to the barbs 222, the opening 216 is notstretched as the barbs 214 pass therethrough, but is rather shifted backand forth by the alternating barbs. After the application of the drivingforce and the anchors 206 having been driven to full deployment, thedriving force is removed and the last barb 214 having passed through theopening 216 for each pin 212 catches against the anchor base 208material surrounding the opening 216, thereby maintaining the closurepressure initially applied by an apparatus for closing the members 202and 204 together against the vessel 205. The apparatus can then beremoved.

Preferably the main body of the deployment member 202 includes aresilient and/or compressible member, suspension, spring, biasing memberto provide a biasing force similar to the towers 30 discussed above. Inthe embodiment of FIG. 65, a cavity or hollow 232 is provided, whichenables the portions of the member 202 opposite the cavity to flex andbend, thereby acting as a spring to assist in maintaining theclosing/sealing pressure on the tissue 205 held between the members 202and 204, but avoid necrosis of the tissue 205 therebetween. Thus, thehollow 232 helps provide a similar variable function as the towers 30 ofthe implant 10 discussed above. Further preferably the main body of thedeployment member 202 is perforated, being provided with through holes233 that extend through the body from a face 234 contacting the tissue205, to allow fluid communication to the tissue 205 between the members202 and 204, further avoiding necrosis and promoting healing/scarring.Optionally, leading ends 235 and 236 of the members 202 and 204,respectively, may have a convex shape and trailing ends 237 and 238 mayhave a concave shape that mates with the convex shape (or vice versa) asshown in FIG. 64, to support end-to-end or head-to-tail placement withanother implant 200 in circumstances where multiple implants need to beinstalled (similar to the head-to-tail arranged discussed above withrespect to the implant 10). Of course the mating shapes are not limitedto concave and convex, as virtually any other mating shapes could beemployed, as well as non-mating shapes.

FIG. 65 is an enlarged view of a leading end portion of the implant 200without showing the tissue for better visualization of the relationshipbetween the anchors 206 and anchor base 208 upon deployment. As can beseen, the anchor base 208 can be provided as a continuous sheet thatruns substantially along the full length and width of the receivermember 204, at least to an extent that extends beyond the length andwidth of the area occupied by the anchors 206 on the opposing deploymentmember 202. Because of this, multiple openings 216 are available foreach distal tip of each pin 212 (or pins 220, 221) of each anchor 206 topotentially pass through. Because of this, less exact alignment isrequired between the anchors 206 and where they are to be anchored, sothat the engineering constraints upon aligning the jaws of the apparatusfor deploying the device and aligning the deployment and receivingmembers are significantly lessened. This leads to a potentially smallerand/or less expensive deployment apparatus. The anchor 206 does not needto be aligned with any particular opening 216, as it can pass throughany opening 216 in the vicinity of where it is driven and then anchoredto the base 208 upon release of driving force in a manner as describedabove. It is again to be appreciated that the implant 10 offered similaradvantages and acceptable performance under even loose tolerances. Theanchor base 208 can be molded into the receiver member 204.Alternatively, the anchor base 208 can be mounted to a face 240 of thereceiver member 204 that faces the deployment member 202 and contactsthe surgical structure. Similar to the deployment member 14 and theretainer 44 of the implant 10 discussed above, the deployment member 202of the implant 200 may include a retainer, e.g. the retainer 210,disposed or embedded therein.

The deployment member 202 may include grooves 217 (preferably formed bymolding, but could be machined or otherwise cut in) to hold the basebodies 213 and thus the anchor 206, prior to deployment. The materialportion of the deployment member 202 between the bases 213 and thesurgical structure is compliant so that it maintains the anchors 206 intension against the retainer 210 after deployment and engagement withthe retainer 210. The face 236 of the deployment member 202 to beapplied to the surgical structure may be provided with ridges 244extending along the sides, which are raised, relative to the remainderof the face 236 to concentrate sealing action away from the anchors 206so as to minimize risks of leakage through the holes in the surgicalstructure formed by piercing through the surgical structure with theanchors 206. Likewise, the face 240 of the receiver member 204 thatfaces the deployment member 202 may be provided with longitudinallyextending ridges similar to the ridges 244 along the side lengthsthereof that extend lower than the remainder of the face 240 so as tominimize the risk of leakage due to the holes pierced through thesurgical structure by the pins 212 on the receiver member 204 side ofthe surgical structure. Slots 248 may be provided in the receiver member204 that may extend from the face 240 of the receiver member 204, andinto shields or protrusions 250 extending dorsally from of the receivermember 204. Protrusions 250 are provided to ensure that the pins 212 ofthe anchors 206 do not extend out of the receiver member 204 afterdeployment (so the tips do not extend beyond the dorsal surface ofreceiver member 204). Protrusions 250 are provided with a heightsufficient to ensure that the pins 212 cannot extend out of the receivermember 204 after deployment, even if there is no surgical structureprovided between the deployment member 202 and the receiver member 204.The protrusions can be solid, or alternatively can form a cavity like ashell.

FIG. 69 is an illustration of a working end portion (distal end portion)of a tool, device, or instrument 300 used to deploy the implants 200described above with regard to FIGS. 64-68. In the embodiment shown, theinstrument 300 and implants 200 may be configured and dimensioned toseal off a vessel, e.g., the vessel 205, or otherwise be used to secure,close, clamp, tack, etc., various tissue and non-tissue surgicalstructures. In one embodiment, the vessel 205 has an outside diameter ofabout 25 mm, and a compressed thickness (between the members 202 and204) of about 0 to about 3 mm, although vessels of other sizes may besealed by use of the instrument 300 and the implant 200. Similar to theimplant 10, suitable surgical structures include vessels, parenchyma,gastrointestinal structures, meshes, grafts, etc.

In the illustrated embodiment, the instrument 300 includes a set of jaws302 a and 302 b (collectively, “the jaws 302”) arranged to receive andengage the members 202 and 204. In one embodiment, the jaws 302 and themembers 202 and 204 are together configured and dimensioned to provideabout a 57 mm sealing length. As already noted, this configuration isnot limiting, as the instrument 300 and implant 200 may be configuredand dimensioned to provide a sealing length that is less than or greaterthan 57 mm. As shown, two implants 200 are releasably mounted in thejaws 302 for delivery and deployment thereof. It is to be appreciatedthat in some embodiments two of the implants 200 may be secured by abridge, e.g., resembling the bridge 37 of FIG. 1, to form a double-rowedimplant resembling two of the implants 200. In other embodiments, asingle implant row, or more than two implant rows can be secured to thejaws. In the illustrated embodiment, the receiver members 204 arereleasably mounted, e.g., via friction, in the jaw 302 a and thedeployment members 202 are releasably mounted, e.g., via friction, inthe jaw 302 b in opposition to the receiver members 204.

The proximal end portion of the instrument is not shown, but theinstrument 300 includes a shaft 318 extending from the support 306 forthe jaws 302 that is connectable to any suitable handle. In oneembodiment, the shaft 306 has a diameter in the range of about 5 mm toabout 10 mm, preferably about 7 mm. The jaws 302 may be articulated inthe manner described above. Other articulation mechanisms are alsocontemplated. The jaws are actuatable to close down on the tissue/vessel205 as shown in FIG. 70, either by pivoting movement of one of the jawstoward the other jaw or by pivoting movement of both of the jaws towardeach other. The jaws 302 can be closed by operation of an actuationmember, such as a trigger (not illustrated) similar to the trigger ofthe embodiment of FIG. 50 described above, so as to close the jawstogether, as illustrated in FIG. 70, a preset distance and/or with apredetermined amount of closing force in the manner described above. Thejaws 302 can be re-opened and repositioned, if desired, prior todeployment of one or more of the implants 200 in the same manner asapplication 500 described above.

Once in the desired position, as shown in FIG. 70, implants may bedeployed by advancing an actuator or driver 308 (FIGS. 71 and 72) from aproximal end of the jaw 302 b to a distal end of the jaw 302 b. In thisembodiment, the driver 308 may comprise a ramped force applicator 310having a ramped surface 312 that is actuated to push or force the bases213 of the anchors 206 toward the surgical structure as the applicator310 passes by the anchors 206 during its traversal from the proximal endto the distal end of the jaw 302 b. The ramped surface 312 of the driver308 in one embodiment may not be rigid, but instead resiliently providea predetermined spring force so as to apply a predetermined amount ofdriving or actuating force to the bases 213 to actuate the anchors 206toward the surgical structure. In one embodiment, the driver 308 appliesa pressure of about 3 to about 30 g/mm{circumflex over ( )}2, andpreferably about 9 g/mm{circumflex over ( )}2 to the anchors 206. Theramped surfaces 312 of the driver 308 are provided on both sides of thejaw 302 b so as to align with both of the implants 200 held by the jaws302. In some embodiments, in between the ramped surfaces 312, the driver308 includes a cutting element 316, such as a sharp blade or knifeconfigured for cutting tissue, vessels, and other surgical structures.Thus, as the actuating driver 308 is distally advanced, the surgicalstructure between the two implants 200 held by the jaws 302 can be cutby the cutting element 316 simultaneously with the actuation of theanchors 206 through the surgical structure and into the anchor base 208for engagement with the retainer 210. The actuating driver 308 can bedriven by various types of different force transferors 318, for example,a rigid or semi-rigid rod, cable, wire, ribbon, or the like, or in themanner of driver 542 described in detail above. The force transferors318 can be driven in compression or tension.

FIG. 71 is an enlarged, partial view of a portion of the instrument 300,showing a proximal portion of the jaws 302 and articulation joint 320connecting the jaws 302 to the shaft 306 that extends proximally fromthe jaws 302, e.g., toward a handle used by a user to manipulate theinstrument 300. The articulation joint 320 in the illustrated embodimenthas one degree of freedom, although it is to be appreciated that furtherdegrees of freedom may be used, e.g., the shaft 306 may be rotatable,etc. The articulation mechanisms of the previously described applicatorcould also be utilized.

FIG. 72 illustrates the driver 308 in its distal position. At thisstage, the driver 308 has completely severed the surgical structurebetween the implants 200 and all of the anchors 206 have been driven bythe predetermined force to squeeze the surgical structure and secure thesurgical structure between the deployment members 202 and the receivermembers 204. Different thickness of the surgical structure along thesealing path result in different driving distances of the anchors 206,as all anchor members are driven up to the same predetermined drivingforce. For example, a relatively smaller thickness of the surgicalstructure requires an anchor 206 to be driven by a greater distance intothe anchor base than does a relatively larger thickness of the surgicalstructure.

After completing the actuating and severing processes discussed withrespect to FIG. 72, the jaws 302 can be opened, at which time theimplants 200 detach from the jaws 302 as the jaws 302 move away from theimplant 200, and the instrument 300 can be removed from the surgicalsite. FIG. 73 shows the deployed, implanted, or installed implants 200that remain in the vessel 205, and a cut 322 between the implants wherethe vessel 205 is severed, thereby transecting the vessel 205. Asdiscussed above with respect to the implant 10, transecting the vessel205 may be used, for example, in a vessel harvesting operation, and thatother tissue and non-tissue structures can be similarly cut by use ofthe implants 200.

FIG. 74 shows one half of the transected or cut vessel 205 and thecorresponding one of the implants 200 in perspective. At the location ofthe cut 322, it can be seen that the vessel 205 has been sealed by thedeployment of the implant 200. Also, it is understood that thedeployment member 202 and receiver member 204 will abut against oneanother at locations where there is no tissue, as represented by a setof lines 326 peripheral to the vessel 205 clamped by the implant 200. Insituations where excessive lengths of the implant 200 extend beyond thesurgical structure, one or both end portions of the closure device canbe cut off (cropped) as shown in FIG. 74. For example, FIG. 75illustrates a vessel 255 having an outside diameter smaller than that ofthe vessel 205 having been transected and sealed using the implant 200as described above. Since fewer of the anchors 206 are needed for thesmaller size of the vessel 255, both ends of the implant 200 that extendbeyond the width of the vessel 255 are illustrated as having been cut orcropped in FIG. 75.

The instrument 300 may be low profile and can be configured anddimensioned so as to be delivered through a port for minimally invasiveprocedures. FIG. 76 is a distal end view of instrument 300 with the jaws302 in a closed configuration, illustrating the compactness of thedesign. A circle 328 represents a port for inserting the jaws 302 of theinstrument 302 through. In one embodiment, the port represented by thecircle 328 has a 12 mm diameter. The instrument 300 can include thearticulation, rotation and implant firing mechanism described above withregards to FIGS. 50-60D, as well as the aforementioned alternatives.

While the invention has been described with reference to an exemplaryembodiment or embodiments, it will be understood by those skilled in theart that various changes may be made and equivalents may be substitutedfor elements thereof without departing from the scope of the invention.In addition, many modifications may be made to adapt a particularsituation or material to the teachings of the invention withoutdeparting from the essential scope thereof. Therefore, it is intendedthat the invention not be limited to the particular embodiment disclosedas the best mode contemplated for carrying out this invention, but thatthe invention will include all embodiments falling within the scope ofthe claims. Also, in the drawings and the description, there have beendisclosed exemplary embodiments of the invention and, although specificterms may have been employed, they are unless otherwise stated used in ageneric and descriptive sense only and not for purposes of limitation,the scope of the invention therefore not being so limited. Moreover, theuse of the terms first, second, etc. do not denote any order orimportance, but rather the terms first, second, etc. are used todistinguish one element from another. Furthermore, the use of the termsa, an, etc. do not denote a limitation of quantity, but rather denotethe presence of at least one of the referenced item.

1-63. (canceled)
 64. A surgical method of sealing tissue comprising:providing a fastener supporting member supporting a plurality offasteners and having a plurality of compressible members; providing areceiver member, clamping tissue between a first surface on the fastenersupporting member and a second surface on the receiver member; andadvancing the plurality of fasteners into the receiver member, theplurality of fasteners compressing the compressible members inaccordance with a distance of advancement of the fasteners, the distancerelating to a thickness of tissue between the first and second surfaces.65. The method according to claim 64, wherein the step of advancing theplurality of fasteners deforms the plurality of compressible members.66. The method according to claim 64, wherein the plurality ofcompressible members flex to absorb excess forces to accommodate anincrease in pressure in sealed tissue.
 67. The method according to claim64, wherein the receiver member includes a retainer positioned therein,and the step of advancing the plurality of fasteners advances theplurality of fasteners into engagement with the retainer.
 68. The methodaccording to claim 67, wherein the fastener supporting member includes aretainer positioned therein, and the step of advancing the plurality offasteners advances the plurality of fasteners through the retainer inthe fastener supporting member.
 69. The method according to claim 67,wherein the retainer has a plurality of openings and barbs of theplurality of fasteners engage the retainer adjacent the openings. 70-83.(canceled)
 84. An end effector assembly of a surgical device comprising:a first jaw; a second jaw, at least one of the first and second jawsmovable toward the other jaw to transition the first and second jawsbetween an open configuration and a closed configuration, wherein thefirst jaw and the second jaw are arranged to receive tissue therebetweenwhen in the open configuration and to clamp the tissue when in theclosed configuration; a fastener supporting member supported by thefirst jaw; a plurality of fasteners supported by the fastener supportingmember; a receiver member supported by the second jaw; a retainerpositioned in the second jaw; and a drive assembly movable with respectto the first jaw to advance the plurality of fasteners toward thereceiver member and into engagement with the retainer to couple togetherthe fastener supporting member and the receiver member.
 85. The endeffector assembly according to claim 84, wherein the drive assembly isoperable to transition the first and second jaws between the openconfiguration and the closed configuration.
 86. The end effectorassembly according to claim 84, wherein the drive assembly is movable indistal and proximal directions, wherein distal movement of the driveassembly advances the plurality of fasteners toward the receiver memberand proximal movement of the drive assembly further advances at leastone of the plurality of fasteners toward the receiver member.
 87. Theend effector assembly according to claim 86, wherein the drive assemblyhas a first ramp at a first angle and a second ramp at a second angle,the first ramp deploying the plurality of fasteners upon distal movementof the drive assembly.
 88. The end effector assembly according to claim84, further comprising a retainer positioned in the first jaw forretaining the plurality of fasteners, the plurality of fasteners advancethrough the retainer when deployed toward the receiver member.
 89. Theend effector assembly according to claim 84, further comprising aplurality of compressible members positioned in the first jaw, whereinadvancement of the plurality of fasteners compresses the plurality ofcompressible members.
 90. The end effector assembly according to claim89, wherein a degree of compression of the plurality of compressiblemembers is dependent on a thickness of tissue clamped between the firstand second jaws.
 91. The end effector assembly according to claim 84,wherein both the first and second jaws are movable toward each other totransition the first and second jaws to the closed configuration. 92.The end effector assembly according to claim 84, wherein only the firstjaw is movable toward the second jaw while the second jaw remainssubstantially stationary to transition the first and second jaws to theclosed configuration.
 93. The end effector assembly according to claim84, wherein the plurality of fasteners are arranged in at least two rowssubstantially parallel to a longitudinal axis of the fastener supportingmember, and a cutting blade is movable between the rows of fasteners tosever tissue. 94-116. (canceled)
 117. A surgical device comprising: ahandle portion at a proximal portion of the device; an elongated portionextending distally from the handle portion; a first jaw and a second jawat a distal portion of the device; a fastener supporting member of asurgical implant supported in the first jaw, the fastener supportingmember supporting a plurality of fasteners; a fastener receiver memberof the surgical implant supported in the second jaw; a plurality ofcompressible members interacting with the plurality of fasteners, theplurality of compressible members having a first configuration prior toadvancement of the plurality of fasteners and a second configurationsubsequent to advancement of the plurality of fasteners; and a driveassembly actuable from the handle portion to sequentially advance theplurality of fasteners against the plurality of compressible members,the plurality of fasteners moving at least some of the plurality ofcompressible members to the second configuration.
 118. The surgicaldevice according to claim 117, wherein in the first configuration theplurality of compressible members have a first height and in the secondconfiguration the plurality of compressible members have a second heightless than the first height.
 119. The surgical device according to claim117, wherein the drive assembly transitions the first and second jaws toa closed configuration, the drive assembly applying a clamping force tothe first and second jaws as the drive assembly moves distally.
 120. Thesurgical device according to claim 117, wherein the drive assembly ismovable in distal and proximal directions, wherein distal movement ofthe drive assembly advances the plurality of fasteners and proximalmovement of the drive assembly further advances at least one of theplurality of fasteners. 121-264. (canceled)